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盐酸伐地那非片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验
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注册号：

Registration number：

 ChiCTR2500108995 

最近更新日期：

Date of Last Refreshed on：

 2025-09-10 10:03:14 

注册时间：

Date of Registration：

 2025-09-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

盐酸伐地那非片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验

Public title：

A single-center, open-label, randomized, single-dose, double-cycle, double-crossover bioequivalence trial of vardenafil hydrochloride tablets in healthy subjects under fasting and postprandial conditions

注册题目简写：

盐酸伐地那非片的生物等效性试验

English Acronym：

Bioequivalence test of vardenafil hydrochloride tablets

研究课题的正式科学名称：

盐酸伐地那非片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验

Scientific title：

A single-center, open-label, randomized, single-dose, double-cycle, double-crossover bioequivalence trial of vardenafil hydrochloride tablets in healthy subjects under fasting and postprandial conditions

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：

杨辉 

研究负责人：

杨辉 

Applicant：

Yang Hui 

Study leader：

Yang Hui 

申请注册联系人电话：

Applicant telephone：

 +86 189 2223 8175

研究负责人电话：

Study leader's
telephone：

+86 20 3485 9951

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：

 yanghui1234359@sina.com

研究负责人电子邮件：

Study leader's E-mail：

 yanghui1234359@sina.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：

广州市番禺区桥南街福愉东路8号

研究负责人通讯地址：

广州市番禺区桥南街福愉东路8号

Applicant address：

8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou City

Study leader's address：

8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou City

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：

广州医科大学附属番禺中心医院

Applicant's institution：

Panyu Central Hospital Affiliated to Guangzhou Medical University

研究负责人所在单位：

广州医科大学附属番禺中心医院

Affiliation of the Leader：

The Affiliated Panyu Central Hospital, Guangzhou Medical University

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：

 PYZXYYEC[2025-026(YW)]-01

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：

广州医科大学附属番禺中心医院药物临床试验伦理委员会

Name of the ethic committee：

Drug Clinical Trial Ethics Committee of Panyu Central Hospital Affiliated to Guangzhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-08-08 00:00:00

伦理委员会联系人：

冯富肩

Contact Name of the ethic committee：

Feng FuJian

伦理委员会联系地址：

广州市番禺区桥南街福愉东路8号

Contact Address of the ethic committee：

8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 3485 9967

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 531177697@qq.com

研究实施负责（组长）单位：

广州医科大学附属番禺中心医院

Primary sponsor：

The Affiliated Panyu Central Hospital, Guangzhou Medical University

研究实施负责（组长）单位地址：

广州市番禺区桥南街福愉东路8号

Primary sponsor's address：

8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

广州医科大学附属番禺中心医院

具体地址：

广州市番禺区桥南街福愉东路8号

Institution
hospital：

The Affiliated Panyu Central Hospital, Guangzhou Medical University

Address：

8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou City

经费或物资来源：

湘北威尔曼制药股份有限公司

Source(s) of funding：

Shohoku Wilman Pharmaceutical Co., LTD

研究疾病：

男性阴茎勃起功能障碍  

Target disease：

Erectile dysfunction of the male penis

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：

 其它 

Study phase：

N/A

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

比较空腹和餐后给药条件下，湘北威尔曼制药股份有限公司提供的盐酸伐地那非片（20mg）与Bayer AG持证的盐酸伐地那非片（20mg，商品名：Levitra®）在健康成年男性中吸收程度和速度的差异，评价其生物等效性。  

Objectives of Study：

To compare the differences in absorption degree and rate between vardenafil hydrochloride tablets (20mg) provided by Xiangbei Weilman Pharmaceutical Co., Ltd. and Bayer Ag-licensed vardenafil hydrochloride tablets (20mg, trade name: Levitra®) in healthy adult men under fasting and postmeal administration conditions, and to evaluate their bioequivalence.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1.过敏体质，如已知对某种物质有过敏史者，或已知对盐酸伐地那非以及相关辅料（微晶纤维素、交联聚维酮、胶态二氧化硅、硬脂酸镁、薄膜包衣预混剂）有既往过敏史者； 2.在研究前筛选阶段或研究用药前发生急性疾病者； 3.既往或现在有下列疾病或慢性/严重病史且研究医生认为目前仍有临床意义者，包括但不限于心血管系统、消化系统、泌尿生殖系统、呼吸系统、血液系统、内分泌系统、免疫系统、精神神经系统、骨骼系统等；特别是患有胃肠功能障碍、消化性溃疡等胃肠疾病有影响药物吸收、分布、代谢和排泄者或3个月内的手术史或计划在研究期间进行手术者； 4.患有不稳定型心绞痛者； 5.患有家族退行性眼部疾病如色素性视网膜炎者或曾出现过色弱或视力丧失者、突发性耳聋或听力丧失者； 6.低血压患者； 7.阴茎具有解剖畸形（如：成角，海绵体纤维化，Peyronie's病）或者阴茎勃起无法消退（如：镰状细胞病，多发性骨髓瘤和白血病）者； 8.6个月内有卒中史或心梗史者； 9.重度肝损伤或需透析的晚期肾病患者； 10.血管穿刺条件差，不能耐受静脉穿刺或有晕针晕血史者； 11.乳糖不耐受者、乳糖酶缺乏或葡萄糖-半乳糖吸收不良病史者（曾发生过喝牛奶腹泻者）； 12.筛选前4周内接受过疫苗接种者，或计划在试验期间或研究结束后1周内接种任何疫苗者； 13.首次用药前14天内使用过任何药物（包括处方药、非处方药、中草药）、保健品和功能性维生素者； 14.筛选前28天内使用任何与伐地那非有相互作用的药物（如：硝酸盐类、CYP 3A4抑制剂（西咪替丁、红霉素、酮康唑、伊曲康唑、克拉霉素、茚地那韦、利托那韦）、α-受体阻滞剂、利奥西呱）者； 15.筛选前3个月内参加过或正在参加其它临床试验并使用过试验用药品或医疗器械干预者； 16.首次给药前3个月内接受过输血或使用过血制品，或有献血史，或其他原因失血超过400mL，或计划在研究期间或研究结束后1周内献血或血液成份者； 17.首次给药前3个月内，平均每周饮酒超过14单位酒精（1单位=360mL啤酒或45mL酒精量为40%的白酒或150mL葡萄酒），或首次给药前48h内和试验期间不能禁酒者，或酒精呼气测试结果大于0mg/100mL者； 18.首次给药前3个月内日均吸烟量≥5支者，或首次给药前48h内和试验期间不能停止使用任何烟草类产品者，包括任何包含尼古丁的戒烟产品； 19.试验前3个月内有药物滥用史（包括非医疗目的反复、大量地使用各类麻醉药品和精神药品）或试验前3个月内使用过毒品者，或药物滥用尿液筛查（包括：吗啡、甲基安非他明（冰毒）、氯胺酮、二亚甲基双氧安非他明（摇头丸）、四氢大麻酚酸（大麻）筛查试验任何一项或多项结果为阳性者； 20.首次给药前48h内摄取过或计划在研究期间摄取咖啡因、酒精类等饮料或食品（包括巧克力、浓茶、咖啡、可乐等）、葡萄柚或葡萄柚产品以及火龙果、芒果、柚子、橘子等影响药物代谢的食品； 21.有吞咽困难者，或对饮食有特殊要求，不能接受统一饮食者； 22.需高空作业、驾驶或操作危险/精密机械者； 23.研究者认为不适宜入组或受试者因个人原因无法参加试验者；

Exclusion criteria：

1.Allergic constitutions, such as those with a known history of allergy to certain substances, or those with a known history of previous allergy to vardenafil hydrochloride and related excipients (microcrystalline cellulose, cross-linked polyvinylidenone, colloidal silica, magnesium stearate, film coating premixes);
2.Those who developed acute diseases during the pre-study screening stage or before the study medication;
3.Those who have had or currently have the following diseases or chronic/severe medical histories and whose research doctors believe that they still have clinical significance at present, including but not limited to the cardiovascular system, digestive system, urogenital system, respiratory system, blood system, endocrine system, immune system, mental and nervous system, skeletal system, etc. Especially for those with gastrointestinal dysfunction, peptic ulcers and other gastrointestinal diseases that affect drug absorption, distribution, metabolism and excretion, or those with a surgical history within 3 months or planning to undergo surgery during the study period;
4.People with unstable angina pectoris;
5.Those who have a family history of degenerative eye diseases such as retinitis pigmentosa, or have experienced color weakness or vision loss, sudden deafness or hearing loss;
6.Patients with hypotension;
7.Those with penile anatomical malformations (such as angulation, cavernous fibrosis, Peyronie's disease) or inability to achieve penile erection (such as sickle cell disease, multiple myeloma and leukemia);
8.Those who have a history of stroke or myocardial infarction within six months;
9.Patients with severe liver injury or advanced kidney disease requiring dialysis;
10.Those with poor conditions for vascular puncture, who cannot tolerate venipuncture or have a history of fainting at the sight of needles and blood;
11.People with lactose intolerance, lactase deficiency or a history of glucose-galactose malabsorption (those who have experienced milk-induced diarrhea);
12.Those who have received a vaccine within 4 weeks before screening, or those who plan to receive any vaccine during the trial or within 1 week after the end of the study;
13.Those who have used any drugs (including prescription drugs, over-the-counter drugs, and Chinese herbal medicines), health supplements, and functional vitamins within 14 days prior to their first medication;
14.Those who have used any drugs that have interacted with vardenafil (such as nitrates, CYP 3A4 inhibitors (cimetidine, erythromycin, ketoconazole, itraconazole, clarithromycin, inddenavir, ritonavir), α -receptor blockers, lioxigumab) within 28 days before screening;
15.Those who have participated in or are currently participating in other clinical trials and have used investigational drugs or medical devices for intervention within the three months prior to screening;
16.Those who have received a blood transfusion or used blood products within 3 months prior to the first administration, or have a history of blood donation, or have lost more than 400mL of blood for other reasons, or plan to donate blood or blood components during the study period or within 1 week after the study ends;
17.Those who consumed an average of more than 14 units of alcohol per week within 3 months prior to the first administration (1 unit =360mL of beer or 45mL of 40% alcohol liquor or 150 ml of wine), or were unable to abdicate alcohol within 48 hours before the first administration and during the trial period, or whose breath alcohol test results were greater than 0mg/100 ml;
18.Those who smoked an average of 5 cigarettes per day within 3 months prior to the first administration, or were unable to discontinue the use of any tobacco products within 48 hours prior to the first administration and during the trial period, including any smoking cessation products containing nicotine;
19.Those who have a history of drug abuse (including repeated and excessive use of various narcotic and psychotropic drugs for non-medical purposes) within 3 months prior to the trial, or have used drugs within 3 months prior to the trial, or have undergone urine screening for drug abuse (including: Those who have positive results in any one or more of the screening tests for morphine, methamphetamine (methamphetamine), ketamine, dimethamphetamine (ecstasy), and tetrahydrocannabinic acid (cannabis);
20.Caffeine, alcoholic beverages or foods (including chocolate, strong tea, coffee, cola, etc.), grapefruit or grapefruit products, as well as pitaya, mango, pomelo, orange and other foods that affect drug metabolism have been consumed or are planned to be consumed during the study period within 48 hours before the first administration;
21.Those who have difficulty swallowing or have special dietary requirements and cannot accept a uniform diet;
22.Those who need to work at heights, drive or operate dangerous or precision machinery;
23.Those who are considered unsuitable for enrollment by the researchers or whose subjects are unable to participate in the trial due to personal reasons;

研究实施时间：

Study execute time：

从 From 2025-09-10 00:00:00至 To 2025-10-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-11 00:00:00 至 To 2025-09-30 00:00:00

干预措施：

Interventions：

组别：

R-T组

样本量：

 52

Group：

R-T group

Sample size：

干预措施：

口服受试制剂

干预措施代码：

Intervention：

Take the test preparation orally

Intervention code：

组别：

T-R组

样本量：

 52

Group：

T-R group

Sample size：

干预措施：

服用参比药物

干预措施代码：

Intervention：

Take the reference drug

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 广州医科大学附属番禺中心医院 

单位级别：

 三级甲等 

Institution
hospital：

The Affiliated Panyu Central Hospital, Guangzhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

消除速率常数

指标类型：

次要指标

Outcome：

λz

Type：

Secondary indicator

测量时间点：

两周期采血时间点

测量方法：

使用线性回归方法计算的半对数药时曲线终末段的斜率的相反数

Measure time point of outcome：

The time points for blood collection in two cycles

Measure method：

The opposite of the slope of the terminal section of the semi-logarithmic drug-time curve calculated by the linear regression method

指标中文名：

峰浓度

指标类型：

主要指标

Outcome：

Cmax

Type：

Primary indicator

测量时间点：

两周期采血时间点

测量方法：

根据血药浓度-时间实测数据直接获得

Measure time point of outcome：

The time points for blood collection in two cycles

Measure method：

It is directly obtained based on the measured data of blood drug concentration and time

指标中文名：

达峰浓度时间

指标类型：

次要指标

Outcome：

Tmax

Type：

Secondary indicator

测量时间点：

两周期采血时间点

测量方法：

根据血药浓度-时间实测数据直接获得

Measure time point of outcome：

The time points for blood collection in two cycles

Measure method：

It is directly obtained based on the measured data of blood drug concentration and time

指标中文名：

半衰期

指标类型：

次要指标

Outcome：

t1/2

Type：

Secondary indicator

测量时间点：

两周期采血时间点

测量方法：

按照ln2/λz计算

Measure time point of outcome：

The time points for blood collection in two cycles

Measure method：

Calculate according to ln2/λz

指标中文名：

表观分布容积

指标类型：

次要指标

Outcome：

Vd/F

Type：

Secondary indicator

测量时间点：

两周期采血时间点

测量方法：

Vd/F=CL/F/λz

Measure time point of outcome：

The time points for blood collection in two cycles

Measure method：

Vd/F=CL/F/λz

指标中文名：

残留面积百分比

指标类型：

次要指标

Outcome：

AUC_%Extrap

Type：

Secondary indicator

测量时间点：

两周期采血时间点

测量方法：

以[(AUC0-∞-AUC0-t)/AUC0-∞]×100%计算

Measure time point of outcome：

The time points for blood collection in two cycles

Measure method：

Calculate with [(AUC0-∞-AUC0-t)/AUC0-∞]×100%

指标中文名：

从0时到无限时间(∞)的药物浓度-时间曲线下面积

指标类型：

主要指标

Outcome：

AUC0-∞

Type：

Primary indicator

测量时间点：

两周期采血时间点

测量方法：

AUC0-∞=AUC0-t +Ct/λz，Ct是最后可准确测定浓度，λz是消除速率常数

Measure time point of outcome：

The time points for blood collection in two cycles

Measure method：

AUC0-∞=AUC0-t +Ct/λz, where Ct is the last accurately measurable concentration and λz is the elimination rate constant

指标中文名：

相对生物利用度

指标类型：

次要指标

Outcome：

F

Type：

Secondary indicator

测量时间点：

两周期采血时间点

测量方法：

F=AUCT/AUCR×100%，AUCT和AUCR分别是受试制剂和参比制剂的AUC

Measure time point of outcome：

The time points for blood collection in two cycles

Measure method：

F=AUCT/AUCR×100%, where AUCT and AUCR are the AUC of the test preparation and the reference preparation, respectively

指标中文名：

清除率

指标类型：

次要指标

Outcome：

CL/F

Type：

Secondary indicator

测量时间点：

两周期采血时间点

测量方法：

CL/F=Dose/AUC0-∞，Dose为给药剂量

Measure time point of outcome：

The time points for blood collection in two cycles

Measure method：

CL/F=Dose/AUC0-∞, where Dose is the administration dose

指标中文名：

从0时到最后一个浓度可准确测定的样品采集时间t的药物浓度-时间曲线下面积

指标类型：

主要指标

Outcome：

AUC0-t

Type：

Primary indicator

测量时间点：

两周期采血时间点

测量方法：

通过线性梯形法则计算：AUC(i, i+1)= (ti+1-ti)(Ci+Ci+1)/2，AUC为所有AUC(i, i+1)之和

Measure time point of outcome：

The time points for blood collection in two cycles

Measure method：

Calculated by the linear trapezoidal rule: AUC(i, i+1)= (ti+1-ti)(Ci+Ci+1)/2, where AUC is the sum of all AUC(i, i+1)

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

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

在研究中每名受试者接受受试制剂或参比制剂的顺序将由随机分配表确定。由统计单位应用SAS（9.4或更高版本）用区组随机法生成随机分配表。在筛选时，每名受试者将使用筛选号进行识别（筛选号按照签署知情同意书的先后顺序进行排序），以S+三位阿拉伯数字表示，如S001、S002、S003......，每位进行筛选的受试者对应唯一的筛选号（如先开展餐后试验，空腹试验的首个筛选号应顺延餐后试验末个筛选号）。试验

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

In the study, the order in which each subject receives the test preparation or the reference preparation will be determined by a random allocation table. The statistical unit shall generate the random allocation table by using the block randomization method with SAS (version 9.4 or higher). During the screening process, each subject will be identified using a screening number (the screening number is sorted in the order of signing the informed consent form), represented by S+ three Arabic numerals, such as S001, S002, S003...... Each subject undergoing screening corresponds to a unique screening number (if a postprandial test is conducted first, the first screening number of the fasting test should be postponed to the last screening number of the postprandial test). On the first day of the trial, randomization will be conducted. Each qualified subject will be assigned a random number in ascending order of the screening number. Random numbers will be assigned to the subjects in ascendin

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：

开放标签

Blinding：

Open-label study

是否共享原始数据：

IPD sharing

是Yes

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）：

国家生物信息中心

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

China Nation center for Bioinformation

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：

电子采集和管理系统和病历报告表

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

EDC and CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-09-10 10:03:08
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