ChiCTR2300071131 版本V1.0 版本创建时间2023/05/05 17:16:45 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300071131 

最近更新日期：

Date of Last Refreshed on：

 2023-05-05 17:16:42 

注册时间：

Date of Registration：

 2023-05-05 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

枸橼酸爱地那非片与克拉霉素、利福平、西咪替丁、硝苯地平、达泊西汀或酒精相互作用及枸橼酸爱地那非片连续多次给药的药代动力学的单中心研究

Public title：

A single center study on the interaction of aildenafil citrate tablets with clarithromycin, rifampicin, cimetidine, nifedipine , dapoxetine or alcohol and the pharmacokinetics of continuous multiple administration of aildenafil citrate tablets

注册题目简写：

English Acronym：

研究课题的正式科学名称：

枸橼酸爱地那非片与克拉霉素、利福平、西咪替丁、硝苯地平、达泊西汀或酒精相互作用及枸橼酸爱地那非片连续多次给药的药代动力学的单中心研究

Scientific title：

A single center study on the interaction of aildenafil citrate tablets with clarithromycin, rifampicin, cimetidine, nifedipine , dapoxetine or alcohol and the pharmacokinetics of continuous multiple administration of aildenafil citrate tablets

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

杨磊 

研究负责人：

崔一民 

Applicant：

Lei Yang 

Study leader：

YiMin Cui 

申请注册联系人电话：

Applicant telephone：

 +86 13716841049

研究负责人电话：

Study leader's
telephone：

+86 13911854192

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 yanglei1020@126.com

研究负责人电子邮件：

Study leader's E-mail：

 cuiymzy@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市北京经济技术开发区宏达中路6号

研究负责人通讯地址：

北京市西城区西什库大街8号

Applicant address：

6 Middle Hongda Road,Beijing Economic Technological Development Area,Beijing,China

Study leader's address：

8 Xishiku Street, Xicheng District, Beijing, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

悦康药业集团股份有限公司

Applicant's institution：

YOUCARE PHARMACEUTICAL GROUP CO,LTD

研究负责人所在单位：

北京大学第一医院

Affiliation of the Leader：

Peking University first Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2022109-002

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

北京大学第一医院生物医学研究伦理委员会

Name of the ethic committee：

Ethics Committee for Biomedical Research , Peking University first Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-01-09 00:00:00

伦理委员会联系人：

汪科

Contact Name of the ethic committee：

Ke Wang

伦理委员会联系地址：

北京市西城区西什库大街8号

Contact Address of the ethic committee：

8 Xishiku Street, Xicheng District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 010-66119025

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 bdyyec@163.com

研究实施负责（组长）单位：

北京大学第一医院

Primary sponsor：

Peking University first Hospital

研究实施负责（组长）单位地址：

北京市西城区西什库大街8号

Primary sponsor's address：

8 Xishiku Street, Xicheng District, Beijing, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

悦康药业集团股份有限公司

具体地址：

经济技术开发区宏达中路6号

Institution
hospital：

YOUCARE PHARMACEUTICAL GROUP CO,LTD

Address：

6 Middle Hongda Road,Beijing Economic Technological Development Area,Beijing,China

经费或物资来源：

悦康药业集团股份有限公司

Source(s) of funding：

Provided by YOUCARE PHARMACEUTICAL GROUP CO,LTD

研究疾病：

勃起功能障碍  

Target disease：

Erectile dysfunction

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

1、研究中国健康男性受试者口服克拉霉素后，对枸橼酸爱地那非片药代动力学特征的影响及两者合并使用的安全性。 2、研究中国健康男性受试者口服利福平后，对枸橼酸爱地那非片药代动力学特征的影响及两者合并使用的安全性。 3、研究中国健康男性受试者口服西咪替丁后，对枸橼酸爱地那非片药代动力学特征的影响及两者合并使用的安全性。 4、研究中国高血压男性受试者口服枸橼酸爱地那非片后，对硝苯地平控释片降压效果的影响及两者合并使用的安全性。 5、研究中国健康男性受试者同时口服枸橼酸爱地那非片和酒精后，枸橼酸爱地那非片药代动力学特征、受试者血压的变化情况及两者合并使用的安全性。 6、研究中国健康男性受试者同时口服枸橼酸爱地那非片和盐酸达泊西汀片后，枸橼酸爱地那非片和盐酸达泊西汀片相互作用的药代动力学特征及两者合并使用的安全性。 7、研究中国健康受试者多次口服30mg枸橼酸爱地那非片的药代动力学特征及耐受性和安全性。  

Objectives of Study：

1. To study the effect of oral administration of clarithromycin on the pharmacokinetics of aildenafil citrate tablets and the safety of the combination of clarithromycin and clarithromycin in Chinese healthy male subjects. 2. To study the effect of oral rifampicin on the pharmacokinetic characteristics of aildenafil citrate tablets and the safety of the combination of the two tablets in Chinese healthy male subjects. 3. To study the effect of oral cimetidine on the pharmacokinetic characteristics of aildenafil citrate tablets and the safety of combination of cimetidine and cimetidine in Chinese healthy male volunteers. 4. To study the effect of oral administration of aildenafil citrate tablets on the antihypertensive effect of nifedipine controlled-release tablets and the safety of combination of the two tablets in Chinese hypertensive male subjects. 5. To study the pharmacokinetic characteristics of aildenafil citrate tablets, the changes of blood pressure and the safety of the combination of the two tablets in Chinese healthy male subjects after oral administration of idinafil citrate tablets and alcohol. 6. To study the pharmacokinetic characteristics and safety of the interaction between aildenafil citrate tablets and dapoxetine hydrochloride tablets in Chinese healthy male volunteers after oral administration of idinafil citrate tablets and dapoxetine hydrochloride tablets. 7 To study the pharmacokinetic characteristics, tolerance and safety of 30mg aildenafil citrate tablets in Chinese healthy volunteers.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1、克拉霉素与枸橼酸爱地那非片相互作用研究 （1）男性受试者，22周岁≤年龄≤70周岁。 （2）受试者体重不低于50公斤，且体重指数BMI（BMI=体重（kg）/身高（m）的平方）在19-30 kg/m2之间（包括临界值）。 （3）受试者必须在试验前对本研究知情同意，并自愿签署书面的知情同意书。 （4）受试者能够与研究者进行良好的沟通并能够依照研究规定完成研究。 2、利福平与枸橼酸爱地那非片相互作用研究 （1）男性受试者，22周岁≤年龄≤45周岁。 （2）受试者体重不低于50公斤，且体重指数BMI（BMI=体重（kg）/身高（m）的平方）在19-30 kg/m2之间（包括临界值）。 （3）受试者必须在试验前对本研究知情同意，并自愿签署书面的知情同意书。 （4）受试者能够与研究者进行良好的沟通并能够依照研究规定完成研究。 3、西咪替丁与枸橼酸爱地那非片相互作用研究 （1）男性受试者，22周岁≤年龄≤45周岁。 （2）受试者体重不低于50公斤，且体重指数BMI（BMI=体重（kg）/身高（m）的平方）在19-30 kg/m2之间（包括临界值）。 （3）受试者必须在试验前对本研究知情同意，并自愿签署书面的知情同意书。 （4）受试者能够与研究者进行良好的沟通并能够依照研究规定完成研究。 4、枸橼酸爱地那非片与硝苯地平控释片相互作用研究 （1）男性受试者，22周岁≤年龄≤60周岁。 （2）具有轻中度原发性高血压病史。 （3）入组前规律服用（≥12周）硝苯地平控释片（60 mg/日/次）。 （4）诊室血压水平筛选期保持稳定（筛选期血压＜140/90 mmHg）。 （5）受试者体重不低于50公斤，且体重指数BMI（BMI=体重（kg）/身高（m）的平方）在19-30 kg/m2（包括临界值）之间。 （6）受试者必须在试验前对本研究知情同意，并自愿签署书面的知情同意书。 （7）受试者能够与研究者做良好的沟通并能够依照研究规定完成研究。 5、酒精与枸橼酸爱地那非片相互作用研究 （1）男性受试者，22周岁≤年龄≤45周岁。 （2）受试者体重不低于50公斤，且体重指数BMI（BMI=体重（kg）/身高（m）的平方）在19-24 kg/m2（包括临界值）之间。 （3）社交饮酒者。 （4）受试者必须在试验前对本研究知情同意，并自愿签署书面的知情同意书。 （5）受试者能够与研究者做良好的沟通并能够依照研究规定完成研究。 6、盐酸达泊西汀片与枸橼酸爱地那非片相互作用研究 （1）男性受试者，22周岁≤年龄≤45周岁。 （2）受试者体重不低于50公斤，且体重指数BMI（BMI=体重（kg）/身高（m）的平方）在19-24 kg/m2（包括临界值）之间。 （3）受试者必须在试验前对本研究知情同意，并自愿签署书面的知情同意书。 （4）受试者能够与研究者做良好的沟通并能够依照研究规定完成研究。 7、枸橼酸爱地那非片在健康受试者中连续多次给药的药代动力学研究 （1）性别：男性5例，女性5例。 （2）年龄：22~45岁，包括边界值。 （3）受试者体重不低于50公斤，且体重指数BMI（BMI=体重（kg）/身高（m）的平方）在19-24 kg/m2之间（包括临界值）。 （4）受试者必须在试验前对本研究知情同意，并自愿签署书面的知情同意书。 （5）受试者能够与研究者进行良好的沟通并能够依照研究规定完成研究

Inclusion criteria

1.Study on the interaction between clarithromycin and aildenafil citrate tablets (1) male subjects, 22 years old ≤ age ≤ 70 years old. (2) the weight of the subjects was not less than 50 kg, and the body mass index (BMI) (BMI= weight (kg) / height (m) squared) was between 19 and 30kg/m2 (including the critical value). (3) the subjects must have informed consent to this study before the experiment, and voluntarily sign a written informed consent form. (4) the subjects were able to communicate well with the researchers and were able to complete the research in accordance with the research regulations. 2. Study on the interaction between rifampicin and aildenafil citrate tablets (1) male subjects, 22 years old ≤ age ≤ 45 years old. (2) the weight of the subjects was not less than 50 kg, and the body mass index (BMI) (BMI= weight (kg) / height (m) squared) was between 19 and 30kg/m2 (including the critical value). (3) the subjects must have informed consent to this study before the experiment, and voluntarily sign a written informed consent form. (4) the subjects were able to communicate well with the researchers and were able to complete the research in accordance with the research regulations. 3.Study on the interaction between cimetidine aildenafil citrate tablets (1) male subjects, 22 years old ≤ age ≤ 45 years old. (2) the weight of the subjects was not less than 50 kg, and the body mass index (BMI) (BMI= weight (kg) / height (m) squared) was between 19 and 30kg/m2 (including the critical value). (3) the subjects must have informed consent to this study before the experiment, and voluntarily sign a written informed consent form. (4) the subjects were able to communicate well with the researchers and were able to complete the research in accordance with the research regulations. 4. Study on the interaction between aildenafil citrate tablets and nifedipine controlled release tablets (1) male subjects, 22 years old ≤ age ≤ 60 years old. (2) have a history of mild to moderate essential hypertension. (3) take nifedipine controlled release tablets regularly (60mg/ / day) before entering the group (≥ 12 weeks). (4) the blood pressure level in the clinic remained stable during the screening period (blood pressure during the screening period < 140/90mmHg). (5) the weight of the subjects was not less than 50 kg, and the body mass index (BMI) (BMI= weight (kg) / height (m) squared) was between 19 and 30kg/m2 (including the critical value). (6) the subjects must have informed consent to this study before the experiment and voluntarily sign a written informed consent form. (7) the subjects were able to communicate well with the researchers and were able to complete the research in accordance with the research regulations. 5. Study on the interaction between alcohol and aildenafel citrate tablets (1) male subjects, 22 years old ≤ age ≤ 45 years old. (2) the weight of the subjects was not less than 50 kg, and the body mass index (BMI) (BMI= weight (kg) / height (m) squared) was between 19 and 24kg/m2 (including the critical value). (3) social drinkers. (4) the subjects must have informed consent to this study before the experiment, and voluntarily sign a written informed consent form. (5) the subjects were able to communicate well with the researchers and were able to complete the research in accordance with the research regulations. 6. Study on the interaction between dapoxetine hydrochloride tablets and aildenafil citrate tablets (1) male subjects, 22 years old ≤ age ≤ 45 years old. (2) the weight of the subjects was not less than 50 kg, and the body mass index (BMI) (BMI= weight (kg) / height (m) squared) was between 19 and 24kg/m2 (including the critical value). (3) the subjects must have informed consent to this study before the experiment, and voluntarily sign a written informed consent form. (4) the subjects were able to communicate well with the researchers and were able to complete the research according to the research regulations. 7. Pharmacokinetic study of aildenafil citrate tablets in healthy volunteers (1) Sex: 5 males and 5 females. (2) Age: 22-45 years old, including boundary value. (3) the weight of the subjects was not less than 50 kg, and the body mass index (BMI) (BMI= weight (kg) / height (m) squared) was between 19 and 24kg/m2 (including the critical value). (4) the subjects must have informed consent to this study before the experiment, and voluntarily sign a written informed consent form. (5)the subjects were able to communicate well with the researchers and were able to complete the research in accordance with the regulations of the study.

排除标准：

1、克拉霉素、利福平或西咪替丁与枸橼酸爱地那非片相互作用研究
（1）入组前4周内接受过重大外科手术。
（2）已知或怀疑对PDE5类抑制剂、枸橼酸爱地那非片、克拉霉素、利福平、西咪替丁或其中的组分（包括矫味剂）过敏或禁忌者。
（3）入组前30天使用过任何抑制或诱导肝脏药物代谢酶的药物（如：诱导剂——巴比妥类、卡马西平、苯妥英、糖皮质激素、奥美拉唑类等；抑制剂——SSRI类抗抑郁药、镇静催眠药、维拉帕米、氟喹诺酮类、抗组胺类等）或任何剂型的硝酸酯类或NO供体类药物。
（4）梅毒、人类免疫缺陷病毒（HIV）抗体、乙型肝炎表面抗原（HBsAg）、丙型肝炎病毒（HCV）抗体血清学检测结果为阳性。
（5）有其它过敏史。
（6）入组前3个月内使用过软毒品（如：摇头丸、KEN粉、麻古类）或入组前一年内使用过硬毒品（如：可卡因、海洛因、冰毒类）者，或尿液药物滥用筛查呈阳性者。
（7）入组前2周内服用过特殊饮食（包括火龙果、芒果、柚子等）或有剧烈运动，或其它影响药物吸收、分布、代谢、排泄等因素者。
（8）入组前48 h摄取了巧克力、任何含咖啡因、或含黄嘌呤食物或饮料。
（9）对饮食有特殊要求，不能遵守统一饮食者。
（10）入组前6个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位=360 mL啤酒或45 mL酒精量为40%的烈酒或150 mL葡萄酒）。
（11）入组前3个月每日超过5支的吸烟史（或相当数量的烟草吸入）或者每日吸烟少于5支，但住院期间无法戒烟者。
（12）入组前3个月内有献血史或失血量超过400 ml或者输注过任何血液或者血液制品。
（13）入组前3个月内参加过任何的临床研究。
（14）在入选整个试验期间至受试者出组后6个月内，受试者及其配偶不愿意或不能采取如下医生认可的避孕措施：如，避孕套、子宫内节育器、避孕环、结扎、禁欲等。
（15）经研究者判定认为不适合参加本项临床试验的受试者。
（16）从事驾车和操作机器类工作的受试者。
仅适用于利福平的排除标准：
（1）有任何可能影响试验安全性或药物体内过程的既往病史或现病史，包括但不限于神经系统、内分泌系统、循环系统、运动系统、呼吸系统、消化系统、泌尿系统、生殖系统等相关疾病。
（2）筛选期经全面体格检查、十二导联心电图检查、生命体征检查（体温、血压、呼吸频率、脉搏）、眼科检查、正位胸片以及实验室检查（血生化、血常规、尿常规、凝血功能）异常有临床意义者（以临床医师判断为准）。
（3）有心血管疾病病史：如严重心律失常、心力衰竭、Adams-Stokes综合征、不稳定型心绞痛、6个月内的心肌梗死病史或中风史、心动过速/心动过缓病史、Ⅱ~Ⅲ度房室传导阻滞或QTcF间期≥450 ms(Fridericia校正公式）等。
仅适用于克拉霉素和西咪替丁的排除标准：
（1）有任何可能影响试验安全性或药物体内过程的既往病史或现病史，包括但不限于神经系统、内分泌系统、循环系统、运动系统、呼吸系统、消化系统、泌尿系统、生殖系统等相关疾病者（如：病毒性肝炎、肝硬化、药物性肝损伤、严重支气管哮喘、慢性支气管炎、慢性阻塞性肺炎病史、急性肾功能衰竭、肾小球肾炎、间质性肾炎、血管性痴呆、阿尔茨海默病、精神病、恶性肿瘤，等）或实验室检查显著异常且有临床意义（如：丙氨酸转氨酶（ALT）/天冬氨酸转氨酶（AST）＞3.0×正常值上限（ULN）；血清肌酐（Cr）＞2.0×ULN等）。
（2）有心血管疾病病史：如未控制的高血压（未经抗高血压治疗，收缩压≥170mmHg和/或舒张压≥105mmHg；使用抗高血压药物治疗，收缩压≥160mmHg和/或舒张压≥100mmHg）、体位性低血压、严重心律失常、心力衰竭、Adams-Stokes综合征、不稳定型心绞痛、6个月内的心肌梗死病史、心动过速/心动过缓病史、Ⅱ~Ⅲ度房室传导阻滞（不包括起搏器植入的患者）或QTcF间期≥450 ms(Fridericia校正公式）。
2、枸橼酸爱地那非片与硝苯地平控释片相互作用研究
（1）过去6个月内有心肌梗塞或患有严重的心血管疾病包括但不限于不稳定性心绞痛、心力衰竭、瓣膜病或有危及生命的心律失常疾病史等。
（2）有任何可能影响试验安全性或药物体内过程的既往病史或现病史，包括但不限于呼吸系统、循环系统、消化系统、血液系统、内分泌系统、免疫系统、皮肤系统、精神神经系统、五官科等相关疾病。
（3）筛选期经全面体格检查、十二导联心电图检查（如QTcF间期≥450 ms(Fridericia校正公式））、生命体征检查（体温、呼吸频率、脉搏（血压除外））、眼科检查、正位胸片以及实验室检查（血生化、血常规、尿常规、凝血功能）异常有临床意义者（以临床医师判断为准）。
（4）HIV检测阳性者或梅毒检测阳性者。
（5）乙型肝炎表面抗原检测阳性或丙型肝炎抗体阳性者。
（6）重度高血压(DBP≥100 mmHg和/或SBP≥160 mmHg)。
（7）入组前30天使用过任何抑制或诱导肝脏药物代谢酶的药物且入组后不能停药；（如：诱导剂——巴比妥类、卡马西平、苯妥英、糖皮质激素、奥美拉唑类等；抑制剂——SSRI类抗抑郁药、西咪替丁、镇静催眠药、维拉帕米、氟喹诺酮类、抗组胺类等）。
（8）入组一周内正在服用除硝苯地平控释片以外的降压药物。
（9）酒精成瘾者，筛选期前3个月内每周饮酒超过14单位（1单位定义为啤酒360 mL或葡萄酒150 mL或白酒45 mL）。
（10）入组前3个月每日超过5支的吸烟史（或相当数量的烟草吸入）或者每日吸烟少于5支，但住院期间无法戒烟者。
（11）入组前3个月内使用过软毒品（如：摇头丸、KEN粉、麻古类）或入组前一年内使用过硬毒品（如：可卡因、海洛因、冰毒类）者，或尿液药物滥用筛查呈阳性者。
（12）已知或怀疑对PDE5类抑制剂、枸橼酸爱地那非片或其中的组分（包括矫味剂）过敏或禁忌者。
（13）对饮食有特殊要求，不能遵守统一饮食者。
（14）入组前2周内服用过特殊饮食（包括火龙果、芒果、柚子等）或有剧烈运动，或其它影响药物吸收、分布、代谢、排泄等因素者。
（15）入组前48 h摄取了巧克力、任何含咖啡因、或含黄嘌呤食物或饮料。
（16）入组前3个月内参加过任何的临床研究。
（17）在入选整个试验期间至受试者出组后6个月内，受试者及其配偶不愿意或不能采取如下医生认可的避孕措施：如，避孕套、子宫内节育器、避孕环、结扎、禁欲等。
（18）研究者认为该患者不适合参加此项研究。
（19）从事驾车和操作机器类工作的受试者。
3、酒精与枸橼酸爱地那非片相互作用研究
（1）入组前4周内患过具有临床意义的重大疾病或接受过重大外科手术者。
（2）过去6个月内有心肌梗塞或中风史以及患有严重的心血管疾病包括但不限于不稳定性心绞痛、心力衰竭或有危及生命的心律失常疾病史等。
（3）有任何可能影响试验安全性或药物体内过程的既往病史或现病史，包括但不限于呼吸系统、循环系统、消化系统、血液系统、内分泌系统、免疫系统、皮肤系统、精神神经系统、五官科等相关疾病。
（4）筛选期经全面体格检查、十二导联心电图检查（如QTcF间期≥450 ms(Fridericia校正公式））、生命体征检查（体温、血压、呼吸频率、脉搏）、眼科检查、正位胸片以及实验室检查（血生化、血常规、尿常规、凝血功能）异常有临床意义者（以临床医师判断为准）。
（5）HIV检测阳性者或梅毒检测阳性者。
（6）乙型肝炎表面抗原检测阳性或丙型肝炎抗体阳性者。
（7）入组前30天使用过任何抑制或诱导肝脏药物代谢酶的药物（如：诱导剂——巴比妥类、卡马西平、苯妥英、糖皮质激素、奥美拉唑类等；抑制剂——SSRI类抗抑郁药、西咪替丁、镇静催眠药、维拉帕米、氟喹诺酮类、抗组胺类等）者。
（8）酒精成瘾者，筛选期前3个月内每周饮酒超过14单位（1单位定义为啤酒360 mL或葡萄酒150 mL或白酒45 mL）。
（9）入组前3个月每日超过5支的吸烟史（或相当数量的烟草吸入）或者每日吸烟少于5支，但住院期间无法戒烟者。
（10）入组前3个月内使用过软毒品（如：摇头丸、KEN粉、麻古类）或入组前一年内使用过硬毒品（如：可卡因、海洛因、冰毒类）者，或尿液药物滥用筛查呈阳性者。
（11）入组前3个月内有献血史或失血量超过400 ml或者输注过任何血液或者血液制品。
（12）已知或怀疑对酒精、PDE5类抑制剂、枸橼酸爱地那非片或其中的组分（包括矫味剂）过敏或禁忌者。
（13）对饮食有特殊要求，不能遵守统一饮食者。
（14）入组前2周内服用过特殊饮食（包括火龙果、芒果、柚子等）或有剧烈运动，或其它影响药物吸收、分布、代谢、排泄等因素者。
（15）入组前48 h摄取了巧克力、任何含咖啡因、或含黄嘌呤食物或饮料。
（16）入组前3个月内参加过任何的临床研究。
（17）在入选整个试验期间至受试者出组后6个月内，受试者及其配偶不愿意或不能采取如下医生认可的避孕措施：如，避孕套、子宫内节育器、避孕环、结扎、禁欲等。
（18）从事驾车和操作机器类工作的受试者。
4、盐酸达泊西汀片与枸橼酸爱地那非片相互作用研究
（1）入组前4周内患过具有临床意义的重大疾病或接受过重大外科手术者。
（2）过去6个月内有心肌梗塞或中风史以及患有严重的心血管疾病包括但不限于不稳定性心绞痛、心力衰竭或有危及生命的心律失常疾病史等。
（3）有任何可能影响试验安全性或药物体内过程的既往病史或现病史，包括但不限于呼吸系统、循环系统、消化系统、血液系统、内分泌系统、免疫系统、皮肤系统、精神神经系统、五官科等相关疾病。
（4）筛选期经全面体格检查、十二导联心电图检查（如QTcF间期≥450 ms(Fridericia校正公式））、生命体征检查（体温、血压、呼吸频率、脉搏）、眼科检查、正位胸片以及实验室检查（血生化、血常规、尿常规、凝血功能）异常有临床意义者（以临床医师判断为准）。
（5）HIV检测阳性者或梅毒检测阳性者。
（6）乙型肝炎表面抗原检测阳性或丙型肝炎抗体阳性者。
（7）入组前30天使用过任何抑制或诱导肝脏药物代谢酶的药物（如：诱导剂——巴比妥类、卡马西平、苯妥英、糖皮质激素、奥美拉唑类等；抑制剂——SSRI类抗抑郁药、西咪替丁、镇静催眠药、维拉帕米、氟喹诺酮类、抗组胺类等）者。
（8）酒精成瘾者，筛选期前3个月内每周饮酒超过14单位（1单位定义为啤酒360 mL或葡萄酒150 mL或白酒45 mL）。
（9）入组前3个月每日超过5支的吸烟史（或相当数量的烟草吸入）或者每日吸烟少于5支，但住院期间无法戒烟者。
（10）入组前3个月内使用过软毒品（如：摇头丸、KEN粉、麻古类）或入组前一年内使用过硬毒品（如：可卡因、海洛因、冰毒类）者，或尿液药物滥用筛查呈阳性者。
（11）入组前3个月内有献血史或失血量超过400 ml或者输注过任何血液或者血液制品。
（12）已知或怀疑对盐酸达泊西汀片、PDE5类抑制剂、枸橼酸爱地那非片或其中的组分（包括矫味剂）过敏或禁忌者。
（13）对饮食有特殊要求，不能遵守统一饮食者。
（14）入组前2周内服用过特殊饮食（包括火龙果、芒果、柚子等）或有剧烈运动，或其它影响药物吸收、分布、代谢、排泄等因素者。
（15）入组前48 h摄取了巧克力、任何含咖啡因、或含黄嘌呤食物或饮料。
（16）入组前3个月内参加过任何的临床研究。
（17）在入选整个试验期间至受试者出组后6个月内，受试者及其配偶不愿意或不能采取如下医生认可的避孕措施：如，避孕套、子宫内节育器、避孕环、结扎、禁欲等。
（18）14天内使用过硫利达嗪或单胺氧化酶抑制剂者。
（19）研究者认为该患者不适合参加此项研究
（20）从事驾车和操作机器类工作的受试者。
5、枸橼酸爱地那非片在健康受试者中连续多次给药的药代动力学研究
（1）入组前4周内接受过重大外科手术。
（2）有任何可能影响试验安全性或药物体内过程的既往病史或现病史，包括但不限于神经系统、内分泌系统、循环系统、运动系统、呼吸系统、消化系统、泌尿系统、生殖系统等相关疾病。
（3）筛选期经全面体格检查、十二导联心电图检查（如男性QTcF间期≥450 ms，女性QTcF间期≥470 ms（Fridericia校正公式））、生命体征检查（体温、血压、呼吸频率、脉搏）、眼科检查、正位胸片以及实验室检查（血生化、血常规、尿常规、便常规及隐血试验、凝血功能）异常有临床意义者（以临床医师判断为准）。
（4）有心血管疾病病史：如严重心律失常、心力衰竭、Adams-Stokes综合征、不稳定型心绞痛、6个月内的心肌梗死病史或中风史、心动过速/心动过缓病史、Ⅱ~Ⅲ度房室传导阻滞等。
（5）已知或怀疑对PDE5类抑制剂、枸橼酸爱地那非片、或其中的组分（包括矫味剂）过敏或禁忌者。
（6）入组前30天使用过任何抑制或诱导肝脏药物代谢酶的药物（如：诱导剂——巴比妥类、卡马西平、苯妥英、糖皮质激素、奥美拉唑类等；抑制剂——SSRI类抗抑郁药、镇静催眠药、维拉帕米、氟喹诺酮类、抗组胺类等）或任何剂型的硝酸酯类或NO供体类药物。
（7）梅毒入组前3个月内使用过软毒品（如：摇头丸、KEN粉、麻古类）或入组前一年内使用过硬毒品（如：可卡因、海洛因、冰毒类）者，或尿液药物滥用筛查呈阳性者。、人类免疫缺陷病毒（HIV）抗体、乙型肝炎表面抗原（HBsAg）、丙型肝炎病毒（HCV）抗体血清学检测结果为阳性。
（8）有其它过敏史。
（9）入组前3个月内使用过软毒品（如：摇头丸、KEN粉、麻古类）或入组前一年内使用过硬毒品（如：可卡因、海洛因、冰毒类）者，或尿液药物滥用筛查呈阳性者。
（10）入组前2周内服用过特殊饮食（包括火龙果、芒果、柚子等）或有剧烈运动，或其它影响药物吸收、分布、代谢、排泄等因素者。
（11）入组前48 h摄取了巧克力、任何含咖啡因、或含黄嘌呤食物或饮料。
（12）对饮食有特殊要求，不能遵守统一饮食者。
（13）入组前6个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位=360 mL啤酒或45 mL酒精量为40%的烈酒或150 mL葡萄酒）。
（14）入组前3个月每日超过5支的吸烟史（或相当数量的烟草吸入）或者每日吸烟少于5支，但住院期间无法戒烟者。
（15）入组前3个月内有献血史或失血量超过400 mL或者输注过任何血液或者血液制品。
（16）入组前3个月内参加过任何的临床研究。
（17）在入选整个试验期间至受试者出组后6个月内，受试者及其配偶不愿意或不能采取如下医生认可的避孕措施：如，避孕套、子宫内节育器、避孕环、结扎、禁欲等。
（18）经研究者判定认为不适合参加本项临床试验的受试者。
（19）从事驾车和操作机器类工作的受试者。

Exclusion criteria：

1.Study on the interaction between clarithromycin, rifampicin or cimetidine and aildenafil citrate tablets
(1)major surgical operations were performed within 4 weeks before entering the group.
(2)people who are known or suspected to be allergic to or contraindicated to PDE5 inhibitors, aildenafil citrate tablets, clarithromycin, rifampicin, cimetidine or their components (including taste modifiers).
(3)any drugs that inhibit or induce liver drug metabolism enzymes (such as inducers--barbital, carbamazepine, phenytoin, glucocorticoids, omeprazole, inhibitors--SSRI antidepressants, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, etc.) or any form of nitrate or NO donor drugs were used in the first 30 days.
(4)the serological tests of syphilis, human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibodies were positive.
(5)have other history of allergy.
(6)those who used soft drugs (such as ecstasy, Ken powder, marijuana) within 3 months before joining the group, or used hard drugs (such as cocaine, heroin, methamphetamine) within one year before joining the group, or tested positive for urinary drug abuse.
(7) those who had taken special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise, or other factors affecting the absorption, distribution, metabolism and excretion of drugs within 2 weeks before entering the group.
(8)Chocolate, any food or drink containing caffeine or xanthine was ingested 48 hours before entering the group.
(9) those who have special requirements for diet and cannot abide by a uniform diet.
(10)regular drinkers in the first 6 months, that is, drinking more than 14 units of alcohol per week (1 unit = 360mL beer or 45mL 40% spirits or 150mL wine).
(11)those who smoked more than 5 cigarettes a day (or a considerable amount of tobacco inhalation) or smoked less than 5 cigarettes a day in the first 3 months, but could not quit smoking during hospitalization.
(12)there is a history of blood donation or blood loss exceeding 400ml or any blood or blood products have been infused within 3 months before joining the group.
(13)participated in any clinical study within 3 months before joining the group.
(14)during the whole trial to 6 months after the subjects were out of the group, the subjects and their spouses were unwilling or unable to take the following contraceptive measures approved by doctors, such as condoms, IUDs, contraceptive rings, ligation, abstinence, etc.
(15)subjects who were determined by the researchers to be unsuitable to participate in this clinical trial.
(16)subjects engaged in driving and operating machines.
Exclusion criteria applicable only to rifampicin: (1) any past or current medical history that may affect the safety of the trial or the process of the drug in vivo, including, but not limited to, nervous system, endocrine system, circulatory system, motor system, respiratory system, digestive system, urinary system, reproductive system and other related diseases. (2) during the screening period, after comprehensive physical examination, 12-lead ECG examination, vital sign examination (body temperature, blood pressure, respiratory rate, pulse), ophthalmology examination, positive position chest X-ray and laboratory examination (blood biochemistry, blood routine, urine routine, blood coagulation function) abnormalities have clinical significance (subject to the judgment of clinicians). (3) History of cardiovascular disease, such as severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina pectoris, history of myocardial infarction or middle wind within 6 months, history of tachycardia / bradycardia, Ⅱ ~ Ⅲ degree atrioventricular block or QTcF interval ≥ 450ms (Fridericia correction formula).
Exclusion criteria applicable only to clarithromycin and cimetidine: (1) any past or current medical history that may affect the safety of the trial or the in vivo process of the drug. Including but not limited to patients with related diseases such as nervous system, endocrine system, circulatory system, motor system, respiratory system, digestive system, urinary system, reproductive system (e.g., viral hepatitis, liver cirrhosis, drug-induced liver injury, severe bronchial asthma, chronic bronchitis, history of chronic obstructive pneumonia, acute renal failure, glomerulonephritis, interstitial nephritis, vascular dementia, Alzheimer's disease, Mental illness, malignant tumor. ) or laboratory tests are significantly abnormal and have clinical significance (for example, alanine aminotransferase (ALT) / aspartate aminotransferase (AST) > 3.0 × normal upper limit (ULN). Serum creatinine (Cr) > 2.0 × ULN, etc.). (2) History of cardiovascular disease: such as uncontrolled hypertension (without antihypertensive treatment, systolic blood pressure ≥ 170mmHg and / or diastolic blood pressure ≥ 105mmHg. Antihypertensive drugs were used, systolic blood pressure ≥ 160mmHg and / or diastolic blood pressure ≥ 100mmHg), postural hypotension, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina pectoris, history of myocardial infarction within 6 months, history of tachycardia / bradycardia, second ~ third degree atrioventricular block (excluding patients with pacemaker implantation) or QTcF interval ≥ 450ms (Fridericia correction formula).
2.Study on the interaction between Aildenafil citrate tablets and Nifedipine controlled release tablets
(1)Myocardial infarction or severe cardiovascular disease including, but not limited to, unstable angina pectoris, heart failure, valvular disease or life-threatening arrhythmia in the past 6 months.
(2)any past or present medical history that may affect the safety of the trial or the process of the drug in vivo, including but not limited to respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, mental nervous system, facial features and other related diseases.
(3)during the screening period, those who underwent comprehensive physical examination, 12-lead ECG examination (such as QTcF interval ≥ 450ms (Fridericia correction formula)), vital sign examination (body temperature, respiratory rate, pulse (except blood pressure), ophthalmology examination, positive chest X-ray and laboratory examination (blood biochemistry, blood routine, urine routine, blood coagulation) had clinical significance (subject to the judgment of clinicians).
(4)those who were positive for HIV or syphilis.
(5)those who were positive for hepatitis B surface antigen or hepatitis C antibody.
(6)severe hypertension (DBP ≥ 100mmHg and / or SBP ≥ 160mmHg).
(7) any drugs that inhibit or induce liver drug metabolic enzymes were used in the first 30 days and can not be stopped after entering the group; (such as: inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.; inhibitors-SSRI antidepressants, cimetidine, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, etc.).
(8)the patients in the group were taking antihypertensive drugs except nifedipine controlled release tablets within one week.
(9)alcoholic addicts drank more than 14 units of alcohol per week in the first 3 months of the screening period (1 unit was defined as beer 360mL or wine 150mL or spirits 45mL).
(10)those who smoked more than 5 cigarettes a day (or a considerable amount of tobacco inhalation) or smoked less than 5 cigarettes a day in the first 3 months, but could not quit smoking during hospitalization.
(11)those who used soft drugs (such as ecstasy, Ken powder, marijuana) within 3 months before joining the group, or used hard drugs (such as cocaine, heroin, methamphetamine) within one year before joining the group, or tested positive for urinary drug abuse.
(12)people who are known or suspected to be allergic to or contraindicated to PDE5 inhibitors, aildenafil citrate tablets or their components (including taste modifiers).
(13)those who have special requirements for diet and cannot abide by a uniform diet.
(14)those who had taken a special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism and excretion within 2 weeks before entering the group.
(15)Chocolate, any food or drink containing caffeine or xanthine was ingested 48 hours before entering the group.
(16)participated in any clinical study within 3 months before joining the group.
(17)during the whole trial to 6 months after the subjects were out of the group, the subjects and their spouses were unwilling or unable to take contraceptive measures approved by doctors, such as condoms, intrauterine devices, contraceptive rings, ligation, abstinence, etc.
(18)the researchers believe that the patient is not suitable to participate in this study.
(19)subjects engaged in driving and operating machines.
3.Study on the interaction between alcohol and aildenafil citrate tablets
(1)those who had suffered from major diseases of clinical significance or had undergone major surgical operations within 4 weeks before entering the group.
(2)there was a history of myocardial infarction or moderate wind in the past 6 months and severe cardiovascular diseases including, but not limited to, unstable angina pectoris, heart failure or a history of life-threatening arrhythmias.
(3)any past or present medical history that may affect the safety of the trial or the process of the drug in vivo, including but not limited to respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, mental nervous system, facial features and other related diseases.
(4)during the screening period, there were clinical significance of comprehensive physical examination, 12-lead ECG examination (such as QTcF interval ≥ 450ms (Fridericia correction formula)), vital sign examination (body temperature, blood pressure, respiratory rate, pulse), ophthalmological examination, positive chest X-ray and laboratory examination (blood biochemistry, blood routine, urine routine, blood coagulation function).
(5)those who were positive for HIV or syphilis.
(6)those who were positive for hepatitis B surface antigen or hepatitis C antibody.
(7)any drugs that inhibit or induce liver drug metabolic enzymes (such as inducers-barbital, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.; inhibitors-SSRI antidepressants, cimetidine, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, etc.).
(8)alcoholic addicts drank more than 14 units of alcohol per week in the first 3 months of the screening period (1 unit was defined as beer 360mL or wine 150mL or spirits 45mL).
(9)those who smoked more than 5 cigarettes a day (or a considerable amount of tobacco inhalation) or smoked less than 5 cigarettes a day in the first 3 months, but could not quit smoking during hospitalization.
(10)those who used soft drugs (such as ecstasy, Ken powder, marijuana) within 3 months before joining the group, or used hard drugs (such as cocaine, heroin, methamphetamine) within one year before joining the group, or tested positive for urinary drug abuse.
(11)there was a history of blood donation or blood loss exceeding 400ml or any blood or blood products were infused within 3 months before joining the group.
(12)people who are known or suspected to be allergic to or contraindicated to alcohol, PDE5 inhibitors, aildenafil citrate tablets or their components (including taste modifiers).
(13)those who have special requirements for diet and cannot abide by a uniform diet.
(14)those who had taken a special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism and excretion within 2 weeks before entering the group.
(15)Chocolate, any food or drink containing caffeine or xanthine was ingested 48 hours before entering the group.
(16)participated in any clinical study within 3 months before joining the group.
(17)during the whole trial to 6 months after the subjects were out of the group, the subjects and their spouses were unwilling or unable to take contraceptive measures approved by doctors, such as condoms, intrauterine devices, contraceptive rings, ligation, abstinence, etc.
(18)subjects engaged in driving and operating machines.
4.Study on the interaction between dapoxetine hydrochloride tablets and aildenafil citrate tablets
(1)patients who had suffered from major diseases of clinical significance or underwent major surgical operations within 4 weeks before entering the group.
(2)there was a history of myocardial infarction or moderate wind in the past 6 months and severe cardiovascular diseases including, but not limited to, unstable angina pectoris, heart failure or a history of life-threatening arrhythmias.
(3)any past or present medical history that may affect the safety of the trial or the process of the drug in vivo, including but not limited to respiratory system, circulatory system, digestive system, blood system, endocrine system, immune system, skin system, mental nervous system, facial features and other related diseases.
(4)during the screening period, there were clinical significance of comprehensive physical examination, 12-lead ECG examination (such as QTcF interval ≥ 450ms (Fridericia correction formula)), vital sign examination (body temperature, blood pressure, respiratory rate, pulse), ophthalmological examination, positive chest X-ray and laboratory examination (blood biochemistry, blood routine, urine routine, blood coagulation function).
(5)those who were positive for HIV or syphilis.
(6)those who were positive for hepatitis B surface antigen or hepatitis C antibody.
(7)any drugs that inhibit or induce liver drug metabolic enzymes (such as inducers-barbital, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.; inhibitors-SSRI antidepressants, cimetidine, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, etc.).
(8)alcoholic addicts drank more than 14 units of alcohol per week in the first 3 months of the screening period (1 unit was defined as beer 360mL or wine 150mL or spirits 45mL).
(9)those who smoked more than 5 cigarettes a day (or a considerable amount of tobacco inhalation) or smoked less than 5 cigarettes a day in the first 3 months, but could not quit smoking during hospitalization.
(10)those who used soft drugs (such as ecstasy, Ken powder, marijuana) within 3 months before joining the group, or used hard drugs (such as cocaine, heroin, methamphetamine) within one year before joining the group, or tested positive for urinary drug abuse.
(11)there was a history of blood donation or blood loss exceeding 400ml or any blood or blood products were infused within 3 months before joining the group.
(12)people who are known or suspected to be allergic to or contraindicated to dapoxetine hydrochloride tablets, PDE5 inhibitors, aildenafil citrate tablets or their components (including taste modifiers).
(13)those who have special requirements for diet and cannot abide by a uniform diet.
(14)those who had taken a special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism and excretion within 2 weeks before entering the group.
(15)Chocolate, any food or drink containing caffeine or xanthine was ingested 48 hours before entering the group.
(16)participated in any clinical study within 3 months before joining the group.
(17)during the whole trial to 6 months after the subjects were out of the group, the subjects and their spouses were unwilling or unable to take contraceptive measures approved by doctors, such as condoms, intrauterine devices, contraceptive rings, ligation, abstinence, etc.
(18)Perthiodazine or monoamine oxidase inhibitor was used within 14 days.
(19)the researchers believe that the patient is not suitable to participate in this study.
(20)subjects engaged in driving and operating machines.
5.Pharmacokinetic study of aildenafil citrate tablets given several times in healthy volunteers
(1)major surgical operations were performed within 4 weeks before entering the group.
(2)any past or present medical history that may affect the safety of the trial or the process of the drug in vivo, including, but not limited to, nervous system, endocrine system, circulatory system, motor system, respiratory system, digestive system, urinary system, reproductive system and other related diseases.
(3)during the screening period, comprehensive physical examination and 12-lead ECG examination (for example, male QTcF interval ≥ 450ms). Female QTcF interval ≥ 470ms (Fridericia correction formula), vital sign examination (body temperature, blood pressure, respiratory rate, pulse), ophthalmology examination, positive position chest X-ray and laboratory examination (blood biochemistry, blood routine, urine routine, stool routine and occult blood test, blood coagulation function) abnormalities have clinical significance (subject to the judgment of clinicians).
(4)History of cardiovascular disease, such as severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina pectoris, history of myocardial infarction or middle wind within 6 months, history of tachycardia / bradycardia, second ~ third degree atrioventricular block, etc.
(5)those who are known or suspected to be allergic to or contraindicated to PDE5 inhibitors, aildenafil citrate tablets, or their components (including taste modifiers).
(6)any drugs that inhibit or induce liver drug metabolism enzymes (such as inducers-barbital, carbamazepine, phenytoin, glucocorticoids, omeprazole, inhibitors-SSRI antidepressants, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, etc.) or any form of nitrate or NO donor drugs were used in the first 30 days.
(7)those who used soft drugs (such as ecstasy, Ken powder, cannabis) within 3 months before entering the group, or used hard drugs (such as cocaine, heroin, methamphetamine) within one year before entering the group, or were positive for urine drug abuse screening. , human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody were positive.
(8)have other history of allergy.
(9)those who used soft drugs (such as ecstasy, Ken powder, marijuana) within 3 months before joining the group, or used hard drugs (such as cocaine, heroin, methamphetamine) within one year before joining the group, or tested positive for urinary drug abuse.
(10)those who had taken a special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism and excretion within 2 weeks before entering the group.
(11)Chocolate, any food or drink containing caffeine or xanthine was ingested 48 hours before entering the group.
(12)those who have special requirements for diet and cannot abide by a uniform diet.
(13)regular drinkers in the first 6 months, that is, drinking more than 14 units of alcohol per week (1 unit = 360mL beer or 45mL 40% spirits or 150mL wine).
(14)those who smoked more than 5 cigarettes a day (or a considerable amount of tobacco inhalation) or smoked less than 5 cigarettes a day in the first 3 months, but could not quit smoking during hospitalization.
(15)there is a history of blood donation or blood loss exceeding 400mL or any blood or blood products have been infused within 3 months before joining the group.
(16)participated in any clinical study within 3 months before joining the group.
(17)during the whole trial to 6 months after the subjects were out of the group, the subjects and their spouses were unwilling or unable to take contraceptive measures approved by doctors, such as condoms, intrauterine devices, contraceptive rings, ligation, abstinence, etc.
(18)subjects who were determined by the researchers to be unsuitable to participate in this clinical trial.
(19) subjects engaged in driving and operating machines.

研究实施时间：

Study execute time：

从 From 2022-09-21 00:00:00至 To 2023-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-02-16 00:00:00 至 To 2023-12-30 00:00:00

干预措施：

Interventions：

组别：

克拉霉素组

样本量：

 18

Group：

clarithromycin tablets

Sample size：

干预措施：

第一天服用60 mg枸橼酸爱地那非片。第三天至第五天分别服用克拉霉素片，一次500mg，一天两次。第六天上午同时服用500 mg克拉霉素片和60 mg枸橼酸爱地那非片，下午服用500 mg克拉霉素片。

干预措施代码：

Intervention：

On the first day, take 60 mg of Eddenafil Citrate tablets. Take clarithromycin tablets 500mg twice a day from the third to the fifth day. On the sixth day, take 500 mg of clarithromycin tablets and 60 mg of aldenafil citrate tablets simultaneously in the morning, and 500 mg of clarithromycin tablets in the afternoon.

Intervention code：

组别：

利福平组

样本量：

 18

Group：

rifampicin capsule

Sample size：

干预措施：

第一天服用60 mg枸橼酸爱地那非片。第三天至第九天分别服用利福平胶囊，一次600 mg，一天一次。第十天同时服用600 mg利福平胶囊和60 mg枸橼酸爱地那非片。

干预措施代码：

Intervention：

On the first day, take 60 mg of Eddenafil Citrate tablets. Take rifampicin capsules 600 mg once a day from the third to the ninth day. On the tenth day, take both 600 mg of rifampicin capsules and 60 mg of aldinafil citrate tablets.

Intervention code：

组别：

西咪替丁组

样本量：

 18

Group：

cimetidine tablets

Sample size：

干预措施：

第一天服用60 mg枸橼酸爱地那非片。第三天至第五天分别服用西咪替丁片，一次400mg，一天两次。第六天上午服用400 mg西咪替丁片和60 mg枸橼酸爱地那非片，下午服用400 mg西咪替丁片。

干预措施代码：

Intervention：

On the first day, take 60 mg of Eddenafil Citrate tablets. Take cimetidine tablets 400mg twice a day from the third to the fifth day. On the sixth day, take 400 mg of cimetidine tablets and 60 mg of aldenafil citrate tablets in the morning, and 400 mg of cimetidine tablets in the afternoon.

Intervention code：

组别：

多次给药

样本量：

 10

Group：

Multiple administration

Sample size：

干预措施：

第一天服用枸橼酸爱地那非片，一次30mg，一天一次，第二天至第六天，每天服用枸橼酸爱地那非片，一次30 mg，一天三次，第七天服用枸橼酸爱地那非片，一次30mg，一天一次。

干预措施代码：

Intervention：

On the first day, take 30mg once a day, once a day, and from the second to sixth days, take 30mg three times a day. On the seventh day, take 30mg once a day, once a day.

Intervention code：

组别：

硝苯地平A组

样本量：

 9

Group：

Nifedipine Group A

Sample size：

干预措施：

第一天服用60 mg硝苯地平控释片，第二天上午服用60 mg硝苯地平控释片，下午服用60 mg枸橼酸爱地那非片，第三天至第四天，服用60 mg硝苯地平控释片，第五天上午服用60 mg硝苯地平控释片，下午服用60 mg枸橼酸爱地那非片模拟剂，第六天，服用60 mg硝苯地平控释片。

干预措施代码：

Intervention：

60 mg nifedipine controlled-release tablet was taken on the first day, 60 mg nifedipine controlled-release tablet was taken on the morning of the second day, 60 mg aidenafil citrate tablet was taken on the afternoon, 60 mg nifedipine controlled-release tablet was taken on the third to the fourth day, 60 mg nifedipine controlled-release tablet was taken on the morning of the fifth day, 60 mg aidenafil citrate tablet simulant was taken on the afternoon, and 60 mg nifedipine controlled-release tablet was taken on the sixth day.

Intervention code：

组别：

硝苯地平B组

样本量：

 9

Group：

Nifedipine Group B

Sample size：

干预措施：

第一天服用60 mg硝苯地平控释片，第二天上午服用60 mg硝苯地平控释片，下午服用60 mg枸橼酸爱地那非片模拟剂，第三天至第四天，服用60 mg硝苯地平控释片，第五天上午服用60 mg硝苯地平控释片，下午服用60 mg枸橼酸爱地那非片，第六天，服用60 mg硝苯地平控释片。

干预措施代码：

Intervention：

60 mg nifedipine controlled-release tablet was taken on the first day, 60 mg nifedipine controlled-release tablet was taken on the morning of the second day, 60 mg aldenafil citrate tablet simulant was taken on the afternoon, 60 mg nifedipine controlled-release tablet was taken on the third to the fourth day, 60 mg nifedipine controlled-release tablet was taken on the morning of the fifth day, 60 mg aldenafil citrate tablet was taken on the afternoon, and 60 mg nifedipine controlled-release tablet was taken on the sixth day.

Intervention code：

组别：

酒精A组

样本量：

 9

Group：

Alcohol Group A

Sample size：

干预措施：

第一天同时服用60 mg枸橼酸爱地那非片和200 mL温开水，经过洗脱期后（七天），第九天同时服用60 mg枸橼酸爱地那非片和200 mL白酒水溶液。

干预措施代码：

Intervention：

On the first day, 60 mg of aldenafil citrate tablets and 200 mL of warm water were taken at the same time. After the washing period (seven days), 60 mg of aldenafil citrate tablets and 200 mL of Baijiu aqueous solution were taken on the ninth day.

Intervention code：

组别：

酒精B组

样本量：

 9

Group：

Alcohol Group B

Sample size：

干预措施：

第一天同时服用60 mg枸橼酸爱地那非片和200 mL白酒水溶液，经过洗脱期后（七天），第九天同时服用60 mg枸橼酸爱地那非片和200 mL温开水。

干预措施代码：

Intervention：

On the first day, 60 mg of adenafel citrate tablets and 200 mL of Baijiu aqueous solution were taken at the same time. After the washing out period (seven days), 60 mg of adenafel citrate tablets and 200 mL of warm water were taken on the ninth day.

Intervention code：

组别：

盐酸达泊西汀A组

样本量：

 6

Group：

Dapoxetine Hydrochloride Group A

Sample size：

干预措施：

第一天服用60 mg枸橼酸爱地那非片，经过7天洗脱期后，第九天服用60 mg盐酸达泊西汀片，经过7天洗脱期后，第十七天服用60 mg枸橼酸爱地那非片和60 mg盐酸达泊西汀片。

干预措施代码：

Intervention：

On the first day, take 60 mg of aldenafil citrate tablets. After a 7-day washout period, take 60 mg of dapoxetine hydrochloride tablets on the ninth day. After a 7-day washout period, take 60 mg of aldenafil citrate tablets and 60 mg of dapoxetine hydrochloride tablets on the seventeenth day.

Intervention code：

组别：

盐酸达泊西汀B组

样本量：

 6

Group：

Dapoxetine Hydrochloride Group B

Sample size：

干预措施：

第一天服用60 mg盐酸达泊西汀片，经过7天洗脱期后，第九天同时服用60 mg枸橼酸爱地那非片和60 mg盐酸达泊西汀片，经过7天洗脱期后，第十七天约8:00服用60 mg枸橼酸爱地那非片。

干预措施代码：

Intervention：

On the first day, take 60 mg of dapoxetine hydrochloride tablets. After a 7-day washout period, on the ninth day, take both 60 mg of aldenafil citrate tablets and 60 mg of dapoxetine hydrochloride tablets. After a 7-day washout period, take 60 mg of aldenafil citrate tablets at approximately 8:00 on the seventeenth day.

Intervention code：

组别：

盐酸达泊西汀C组

样本量：

 6

Group：

Dapoxetine Hydrochloride Group C

Sample size：

干预措施：

第一天同时服用60 mg枸橼酸爱地那非片和60 mg盐酸达泊西汀片，经过7天洗脱期后，第九天服用60 mg枸橼酸爱地那非片，经过7天洗脱期后，第十七天服用60 mg盐酸达泊西汀片。

干预措施代码：

Intervention：

On the first day, take both 60 mg of aldenafil citrate tablets and 60 mg of dapoxetine hydrochloride tablets. After a 7-day washout period, take 60 mg of aldenafil citrate tablets on the ninth day. After a 7-day washout period, take 60 mg of dapoxetine hydrochloride tablets on the seventeenth day.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 北京大学第一医院 

单位级别：

 三级甲等 

Institution
hospital：

Peking University First Hospital

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

用药后观测到的血药峰浓度

指标类型：

主要指标

Outcome：

Cmax

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

从零时到最后一个可检测到血药浓度的时间内曲线下面积

指标类型：

主要指标

Outcome：

AUC0-t

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

从零外推至无穷远时间的曲线下面积

指标类型：

主要指标

Outcome：

AUC0-∞

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

达峰时间

指标类型：

主要指标

Outcome：

Tmax

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

终末端消除半衰期

指标类型：

主要指标

Outcome：

t1/2z

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

表观分布容积

指标类型：

主要指标

Outcome：

Vz/F

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

表观清除率

指标类型：

主要指标

Outcome：

CLz/F

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

消除速率常数

指标类型：

主要指标

Outcome：

λz

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

从零时到最后一个可检测到血药浓度的时间内的平均驻留时间

指标类型：

主要指标

Outcome：

MRT0-t

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

从零外推至无穷远时间的平均驻留时间

指标类型：

主要指标

Outcome：

MRT0-∞

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

残留面积百分比

指标类型：

主要指标

Outcome：

AUC_%Extrap

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血压

指标类型：

主要指标

Outcome：

pressure

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良反应

指标类型：

次要指标

Outcome：

AE

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

尿液

组织：

Sample Name：

Urine fluid

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 22 岁 years
最大 Max age 70 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

枸橼酸爱地那非与硝苯地平控释片、酒精、盐酸达泊西汀片的相互作用研究需进行随机入组。随机表由独立统计师通过使用SAS 9.4 PROC PLAN过程产生。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The interaction of aildenafil citrate tablets with nifedipine controlled release tablets, alcohol and dapoxetine hydrochloride tablets should be randomly divided into groups. Random tables are generated by independent statisticians through the use of the SAS9.4PROCPLAN process.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

枸橼酸爱地那非与硝苯地平控释片的相互作用研究需要设盲。

Blinding：

The study of the interaction between aildenafil citrate tablets and nifedipine controlled-release tablets needs to be blinded.

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

ResMan

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

ResMan

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

NA

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

NA

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-05-05 17:16:42