ChiCTR2300071119 版本V1.0 版本创建时间2023/05/05 15:15:07 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：

 ChiCTR2300071119 

最近更新日期：

Date of Last Refreshed on：

 2023-05-05 15:15:04 

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：

枸橼酸爱地那非片在特殊人群中的药代动力学的开放、单次、单中心研究

Public title：

An open, single, single center study on the pharmacokinetics of Aildenafil Citrate Tablets in a specific population

注册题目简写：

English Acronym：

研究课题的正式科学名称：

枸橼酸爱地那非片在特殊人群中的药代动力学的开放、单次、单中心研究

Scientific title：

An open, single, single center study on the pharmacokinetics of Aildenafil Citrate Tablets in a specific population

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 Hongda Road, Beijing Economic and Technological Development Zone, Beijing, China

Study leader's address：

8 Xishiku St, Xicheng District, Beijing

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：

 2022108-002

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：

 2022-11-24 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 St, Xicheng District, Beijing

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：

 bdyyeca163.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 St, Xicheng District, Beijing

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：

单臂 

Study design：

Single arm 

研究目的：

评价枸橼酸爱地那非片在老年人群中的安全性及药代动力学特征；评价枸橼酸爱地那非片在中度肝功能损伤人群中的安全性及药代动力学特征；评价枸橼酸爱地那非片在II型糖尿病人群中的安全性及药代动力学特征。  

Objectives of Study：

To evaluate the safety and pharmacokinetic characteristics of aldinafil citrate tablets in the elderly population. To evaluate the safety and pharmacokinetic characteristics of aldinafil citrate tablets in patients with moderate liver function injury. To evaluate the safety and pharmacokinetic characteristics of aldenafil citrate tablets in type II diabetes patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

老年人组
（1）男性受试者，年龄≥65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19-30kg/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。
肝损伤患者组
（1）男性受试者，22周岁≤年龄≤70周岁。
（2）中度肝功能损伤患者（根据Child-Pugh诊断标准，评分为7~9分，分级为B级）。
（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19-30 kg/m2之间（包括临界值）。
（4）受试者肝功能状态稳定，表现为近2周肝损伤的临床症状或实验室指标差异较小（以临床医师判定为准）。
（5）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。
（6）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。
糖尿病患者组
（1）男性受试者，22周岁≤年龄≤70周岁。
（2）II型糖尿病（T2MD）患者被确诊至少3个月。
（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19-30 kg/m2之间（包括临界值）。
（4）糖化血红蛋白（HbA1c）在6.5%~11%之间。
（5）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。
（6）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

Elderly group
（1）Male subject, age≥65 years old.
（2）The subject weighs not less than 50 kg and has a body mass index (BMI=square of body weight (kg)/height (m)) between 19-30 kg/m2 (including a threshold).
（3）Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.
（4）Subjects are able to communicate well with the researcher and complete the study in accordance with the research regulations.
Liver injury patient group
（1）Male subject, 22 years old≤age≤70 years old
（2）Patients with moderate liver function injury (based on the Child-Pugh diagnostic criteria, with a score of 7 to 9, and a grade of B)
（3）Subjects weigh not less than 50 kg and have a body mass index (BMI=square of body weight (kg)/height (m)) between 19-30 kg/m2 (including threshold values)
（4）The liver function status of the subject is stable, and there is little difference in clinical symptoms or laboratory indicators of liver injury in the past 2 weeks (subject to the judgment of the clinician).
（5）Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.
（6）Subjects are able to communicate well with the researcher and complete the study in accordance with the research regulations.
Diabetes group
（1）Male subject, 22 years old ≤age≤70 years old.
（2）Type II diabetes (T2MD) patients have been diagnosed for at least 3 months.
（3）Subjects weigh not less than 50 kg and have a body mass index (BMI=square of body weight (kg)/height (m)) between 19-30 kg/m2 (including threshold values).
（4）Glycosylated hemoglobin (HbA1c) is between 6.5% and 11%.
（5）Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.
（6）Subjects are able to communicate well with the researcher and complete the study in accordance with the research regulations.

排除标准：

老年人组
（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、西咪替丁、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、慢性阻塞性肺疾病病史、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）。
（6）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）。
（7）有其它过敏史。
（8）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。
（9）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。
（10）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。
（11）对饮食有特殊要求，不能遵守统一饮食者。
（12）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）。
（13）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。
（14）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。
（15）入组前3个月内参加过任何的临床研究。
（16）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。
（17）经研究者判定认为不适合参加本项临床试验的受试者。
肝损伤患者组
（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、西咪替丁、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）抗体血清学检测结果为阳性。
（5）有任何可能影响试验安全性或药物体内过程的但与肝功能损伤无相关性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：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，以临床医师判断为准，不包括伴随肝功能状态分级为B级出现的异常有临床意义的相关检查指标。
（6）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）。
（7）近一个月内确诊为活动性Ⅲ期~Ⅳ期肝性脑病的受试者。
（8）近一个月存在肝功能波动或恶化，或者根据其临床症状或实验室指标研究者判定为病情恶化的受试者。
（9）近一个月内有严重腹水和/或需要定期进行穿刺术的受试者。
（10）有其它过敏史。
（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）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。
（13）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。
（14）对饮食有特殊要求，不能遵守统一饮食者。
（15）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）。
（16）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。
（17）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（人血白蛋白注射液除外）。
（18）入组前3个月内参加过任何的临床研究。
（19）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。
（20）经研究者判定认为不适合参加本项临床试验的受试者。
糖尿病患者组
（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、西咪替丁、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）有任何可能影响试验安全性或药物体内过程的但与糖尿病无相关性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），以临床医师判断为准，不包括伴随糖尿病出现的异常有临床意义的相关检查指标。
（6）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）。
（7）有已知Ⅰ型糖尿病病史或合并存在Ⅰ型糖尿病的受试者。
（8）糖尿病并发症（急性代谢性糖尿病并发症，如酮症酸中毒、低血糖昏迷等）。
（9）有其它过敏史。
（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。
（12）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。
（13）对饮食有特殊要求，不能遵守统一饮食者。
（14）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）。
（15）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。
（16）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。
（17）入组前3个月内参加过任何的临床研究。
（18）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。
（19）经研究者判定认为不适合参加本项临床试验的受试者。

Exclusion criteria：

Elderly group
(1) Major surgery was performed within 4 weeks before enrollment.
(2) Persons who are known or suspected of being allergic or contraindicated to PDE5 inhibitors, aldenafil citrate tablets, or components thereof (including flavor correction agents).
(3) Any drugs that inhibit or induce liver drug metabolism enzymes (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.; inhibitors - SSRI antidepressants, cimetidine, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, etc.) or any dosage form of nitrate or NO donor drugs have been used 30 days before enrollment.
(4) The serological test results for syphilis, human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies were positive.
(5) Any past or current medical history that may affect the safety of the test or the in vivo process of the drug, including but not limited to the nervous system, endocrine system, circulatory system, motor system, respiratory system, digestive system, urinary system Persons with reproductive system and other related diseases (such as viral hepatitis, liver cirrhosis, drug-induced liver injury, severe bronchial asthma, chronic bronchitis, chronic obstructive pulmonary disease history, acute renal failure, glomerulonephritis, interstitial nephritis, vascular dementia, Alzheimer's disease, psychosis, malignant tumors, etc.) or laboratory tests with significant abnormalities and clinical significance (such as alanine aminotransferase (ALT) /Aspartate transaminase (AST) ＞ 3.0 × Upper limit of normal value (ULN); Serum creatinine (Cr) ＞ 2.0 × ULN, etc.).
(6) Have a history of cardiovascular disease, such as uncontrolled hypertension (systolic blood pressure ≥ 170mmHg and/or diastolic blood pressure ≥ 105mmHg without antihypertensive treatment; systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg with antihypertensive drug treatment), postural hypotension, severe arrhythmia, heart failure, Adams Stokes syndrome, unstable angina pectoris, history of myocardial infarction within 6 months, history of tachycardia/bradycardia Grade II to III atrioventricular block (excluding patients with pacemaker implantation) or QTcF interval ≥ 450 ms (Fridericia correction formula).
(7) Have a history of other allergies.
(8) Those who have used soft drugs (such as ecstasy, KEN powder, and ephedrine) within 3 months before enrollment, or those who have used hard drugs (such as cocaine, heroin, and methamphetamine) within one year before enrollment, or those who have been screened positive for urinary drug abuse.
(9) Those who have taken special diet (including pitaya, mango, grapefruit, etc.) or had severe exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before enrollment.
(10) Chocolate, any caffeinated, or xanthine-containing foods or beverages were consumed 48 hours before enrollment.
(11) Those who have special dietary requirements and cannot follow a unified diet.
(12) Regular drinkers within the first 6 months of enrollment, i.e., those who drink more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine).
(13) A history of smoking more than 5 cigarettes per day (or a significant amount of tobacco inhalation) or smoking less than 5 cigarettes per day during the first 3 months of enrollment, but unable to quit during hospitalization.
(14) There is a history of blood donation or a blood loss exceeding 400 ml or any blood or blood products have been transfused within 3 months before enrollment.
(15) I have participated in any clinical research within 3 months before enrollment.
(16) During the entire trial period and within 6 months after the subject's withdrawal from the group, the subject and his spouse were unwilling or unable to take the following contraceptive measures approved by the doctor: condoms, intrauterine devices, contraceptive rings, ligation, abstinence, etc.
(17) Subjects who have been determined by the investigator to be unsuitable for participation in this clinical trial.
Liver injury patient group
(1) Major surgery was performed within 4 weeks before enrollment.
(2) Persons who are known or suspected of being allergic or contraindicated to PDE5 inhibitors, aldenafil citrate tablets, or components thereof (including flavor correction agents).
(3) Any drugs that inhibit or induce liver drug metabolism enzymes (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.; inhibitors - SSRI antidepressants, cimetidine, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, etc.) or any dosage form of nitrate or NO donor drugs have been used 30 days before enrollment.
(4) The serological test results of syphilis and human immunodeficiency virus (HIV) antibodies were positive.
(5) Any past or current medical history that may affect the safety of the test or the in vivo process of the drug but is not related to liver function damage, including but not limited to the nervous system, endocrine system, circulatory system, motor system, respiratory system, digestive system, urinary system Patients with reproductive system and other related diseases (such as severe bronchial asthma, chronic bronchitis, chronic obstructive pneumonia, acute renal failure, glomerulonephritis, interstitial nephritis, vascular dementia, Alzheimer's disease, psychosis, malignant tumors, etc.) or laboratory tests that are significantly abnormal and have clinical significance shall be subject to the judgment of the clinician, It does not include clinically significant relevant examination indicators associated with abnormalities in the liver function status grading as Grade B.
(6) Have a history of cardiovascular disease, such as uncontrolled hypertension (systolic blood pressure ≥ 170mmHg and/or diastolic blood pressure ≥ 105mmHg without antihypertensive treatment; systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg with antihypertensive drug treatment), postural hypotension, severe arrhythmia, heart failure, Adams Stokes syndrome, unstable angina pectoris, history of myocardial infarction within 6 months, history of tachycardia/bradycardia Grade II to III atrioventricular block (excluding patients with pacemaker implantation) or QTcF interval ≥ 450 ms (Fridericia correction formula).
(7) Subjects who have been diagnosed with active phase III to IV hepatic encephalopathy within the past month.
(8) Subjects who have experienced fluctuations or deterioration in liver function in the past month, or who have been judged to have worsened by researchers based on their clinical symptoms or laboratory indicators.
(9) Subjects who have severe ascites within the past month and/or require regular puncture surgery.
(10) Have a history of other allergies.
(11) Those who have used soft drugs (such as ecstasy, KEN powder, and ephedrine) within 3 months before enrollment, or those who have used hard drugs (such as cocaine, heroin, and methamphetamine) within one year before enrollment, or those who have been screened positive for urinary drug abuse.
(12) Those who have taken special diet (including pitaya, mango, grapefruit, etc.) or had severe exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before enrollment.
(13) Chocolate, any caffeinated, or xanthine-containing foods or beverages were consumed 48 hours before enrollment.
(14) Those who have special dietary requirements and cannot follow a unified diet.
(15) Regular drinkers within the first 6 months of enrollment, i.e., those who drink more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine).
(16) A history of smoking more than 5 cigarettes per day (or a significant amount of tobacco inhalation) or smoking less than 5 cigarettes per day during the first 3 months of enrollment, but unable to quit during hospitalization.
(17) Have a history of blood donation or blood loss exceeding 400 ml or have received any transfusion of blood or blood products (excluding human albumin injection) within 3 months before enrollment.
(18) I have participated in any clinical research within 3 months before enrollment.
(19) During the entire trial period and within 6 months after the subject's withdrawal from the group, the subject and his spouse were unwilling or unable to take the following contraceptive measures approved by the doctor: condoms, intrauterine devices, contraceptive rings, ligation, abstinence, etc.
(20) Subjects who have been determined by the investigator to be unsuitable for participation in this clinical trial.
Diabetes group
(1) Major surgery was performed within 4 weeks before enrollment.
(2) Persons who are known or suspected of being allergic or contraindicated to PDE5 inhibitors, aldenafil citrate tablets, or components thereof (including flavor correction agents).
(3) Any drugs that inhibit or induce liver drug metabolism enzymes (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, etc.; inhibitors - SSRI antidepressants, cimetidine, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, etc.) or any dosage form of nitrate or NO donor drugs have been used 30 days before enrollment.
(4) The serological test results for syphilis, human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibodies were positive.
(5) Any past or present medical history that may affect the safety of the test or the in vivo process of the drug but is not related to diabetes, including but not limited to the nervous system, endocrine system, circulatory system, motor system, respiratory system, digestive system, urinary system Persons with reproductive system and other related diseases (such as viral hepatitis, liver cirrhosis, drug-induced liver injury, severe bronchial asthma, chronic bronchitis, chronic obstructive pneumonia, acute renal failure, glomerulonephritis, interstitial nephritis, vascular dementia, Alzheimer's disease, psychosis, malignant tumors, etc.) or laboratory tests with significant abnormalities and clinical significance (such as alanine aminotransferase (ALT) /Aspartate transaminase (AST) ＞ 3.0 × Upper limit of normal value (ULN); Serum creatinine (Cr) ＞ 2.0 × ULN, etc.), based on the judgment of the clinician, excluding the clinically significant related examination indicators associated with diabetes.
(6) Have a history of cardiovascular disease, such as uncontrolled hypertension (systolic blood pressure ≥ 170mmHg and/or diastolic blood pressure ≥ 105mmHg without antihypertensive treatment; systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg with antihypertensive drug treatment), postural hypotension, severe arrhythmia, heart failure, Adams Stokes syndrome, unstable angina pectoris, history of myocardial infarction within 6 months, history of tachycardia/bradycardia Grade II to III atrioventricular block (excluding patients with pacemaker implantation) or QTcF interval ≥ 450 ms (Fridericia correction formula).
(7) Subjects with known history of type I diabetes or with type I diabetes.
(8) Complications of diabetes (acute metabolic diabetes complications, such as ketoacidosis, hypoglycemic coma, etc.).
(9) Have a history of other allergies.
(10) Those who have used soft drugs (such as ecstasy, KEN powder, and ephedrine) within 3 months before enrollment, or those who have used hard drugs (such as cocaine, heroin, and methamphetamine) within one year before enrollment, or those who have been screened positive for urinary drug abuse.
(11) Those who have taken special diet (including pitaya, mango, grapefruit, etc.) or had severe exercise or other factors that affect drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before enrollment.
(12) Chocolate, any caffeinated, or xanthine-containing foods or beverages were consumed 48 hours before enrollment.
(13) Those who have special dietary requirements and cannot follow a unified diet.
(14) Regular drinkers within the first 6 months of enrollment, i.e., those who drink more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine).
(15) A history of smoking more than 5 cigarettes per day (or a significant amount of tobacco inhalation) or smoking less than 5 cigarettes per day during the first 3 months of enrollment, but unable to quit during hospitalization.
(16) There is a history of blood donation or a blood loss exceeding 400 ml or any blood or blood products have been transfused within 3 months before enrollment.
(17) I have participated in any clinical research within 3 months before enrollment.
(18) During the entire trial period and within 6 months after the subject's withdrawal from the group, the subject and his spouse were unwilling or unable to take the following contraceptive measures approved by the doctor: condoms, intrauterine devices, contraceptive rings, ligation, abstinence, etc.
(19) Subjects who have been determined by the investigator to be unsuitable for participation in this clinical trial.

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 2023-02-07 00:00:00 至 To 2023-12-30 00:00:00

干预措施：

Interventions：

组别：

老年人组

样本量：

 10

Group：

Elderly group

Sample size：

干预措施：

枸橼酸爱地那非片

干预措施代码：

Intervention：

Aildenafil Citrate Tablets

Intervention code：

组别：

糖尿病患者组

样本量：

 10

Group：

Diabetes group

Sample size：

干预措施：

枸橼酸爱地那非片

干预措施代码：

Intervention：

Aildenafil Citrate Tablets

Intervention code：

组别：

肝损伤患者组

样本量：

 10

Group：

Liver injury patient group

Sample size：

干预措施：

枸橼酸爱地那非片

干预措施代码：

Intervention：

Aildenafil Citrate Tablets

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：

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：

静脉采血

Sample Name：

Blood

Tissue：

Venous blood collection

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

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 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

不适用

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

N/A

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：

Blinding：

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：

无/No

注册人：

Name of Registration：

  2023-05-05 15:15:04