ChiCTR2500109728 版本V1.0 版本创建时间2025/09/24 11:54:51 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：

 ChiCTR2500109728 

最近更新日期：

Date of Last Refreshed on：

 2025-09-24 11:54:39 

注册时间：

Date of Registration：

 2025-09-24 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

苯磺酸左氨氯地平片生物等效性试验

Public title：

Bioequivalence test of levamlodipine besylate tablets

注册题目简写：

English Acronym：

研究课题的正式科学名称：

苯磺酸左氨氯地平片在中国健康受试者中单中心、随机、开放、单剂量、两制剂、两周期、两序列、双交叉、空腹/餐后状态下生物等效性试验

Scientific title：

Bioequivalence of levamlodipine besylate tablets in a single center, randomized, open, single dose, two-formulation, two-cycle, two-sequence, double-crossed, fasting/postprandial state in Chinese healthy subjects

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 18922238175

研究负责人电话：

Study leader's
telephone：

+86 20 34859951

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：

No. 8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou City

Study leader's address：

No. 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：

The Affiliated Panyu Central Hospital of Guangzhou Medical Universily

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[2024-011(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：

 2024-07-01 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：

No. 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 34859967

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：

No. 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：

No. 8 Fuyu East Road, Qiaonan Street, Panyu District, Guangzhou City

经费或物资来源：

济南高华制药有限公司

Source(s) of funding：

Jinan Gaohua Pharmaceutical Co., LTD

研究疾病：

高血压,冠心病  

Target disease：

High blood pressure, Coronary heart disease

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：

本试验以济南高华制药有限公司生产的苯磺酸左氨氯地平片（规格：5mg）为受试制剂，以辉瑞制药有限公司生产的苯磺酸氨氯地平片（商品名：络活喜?；规格：10mg）为参比制剂，分别考察空腹和餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数，评价两制剂的生物等效性。  

Objectives of Study：

Levamlodipine besylate produced by Jinan Gaohua Pharmaceutical Co., LTD. (specification: 5mg) was used as the test preparation, and amlodipine besylate produced by Pfizer Pharmaceutical Co., LTD. (Trade name: Loxil ?; Specification: 10mg) was used as the reference preparation. The pharmacokinetic parameters of the tested preparation and the reference preparation in healthy subjects under fasting and postprandial conditions were investigated, respectively, and the bioequivalence of the two preparations was evaluated.

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.充分了解试验目的、性质、方法以及可能发生的不良反应，自愿作为受试者，并在任何研究程序开始前由本人签署知情同意书且保证在整个试验过程中由本人参与试验；
2.年龄为18~55周岁（包含18周岁和55周岁）的男性或女性；
3.男性体重≥50.0kg，女性体重≥45.0kg；体重指数（BMI）在18.5~26.0kg/m2范围内（包括临界值，BMI=体重（kg）/身高（m2））；
4.在筛选期及未来3个月内无妊娠计划且自愿采取有效避孕措施（附录2）且无捐精、捐卵计划；
5.能够和研究者进行良好的沟通，并且理解和遵守本项研究的各项要求者。

Inclusion criteria

1.Fully understand the purpose, nature, method and possible adverse reactions of the experiment, voluntarily act as a subject, and sign informed consent by myself before the start of any research procedure and guarantee that I will participate in the experiment during the whole process; 2.Male or female aged 18-55 years (including 18 and 55 years); 3.Male weight >=50.0kg, female weight >=45.0kg; Body mass index (BMI) in the range of 18.5~26.0kg/m^2 (including the critical value, BMI= weight (kg)/height (m^2)); 4.Have no pregnancy plan during the screening period and the next 3 months, voluntarily take effective contraceptive measures (Appendix 2), and have no sperm or egg donation plan; 5.Be able to communicate well with the researcher and understand and comply with the requirements of the study.

排除标准：

1.对氨氯地平或制剂辅料（如乳糖）过敏者，或已知对任何药物、食物等过敏，或有特异性变态反应病史（如哮喘、风疹、湿疹性皮炎）或为严重的过敏体质，且经研究者判断有临床意义者；
2.有吞咽困难或任何影响药物吸收的胃肠道疾病史者；
3.存在任何血液循环系统、消化系统、泌尿系统、呼吸系统、神经系统、免疫系统、内分泌系统、精神异常或代谢异常等任何慢性或严重疾病史，或可能干扰试验结果的任何其他疾病，或3个月内的手术史；
4.患有任何增加出血性风险的疾病者，如急性胃炎或活动性溃疡伴出血、具有临床意义的血小板减少或贫血，以及有活动性病理性出血或有颅内出血病史者；
5.血管穿刺条件差，或不能耐受静脉穿刺，或有晕针晕血史者；
6.筛选前6个月内有药物滥用史者，或筛选前3个月内使用过毒品者，包括非医疗目的反复、大量地使用各类麻醉药品和精神药物，或尿液成瘾药物吗啡、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；
7.筛选前 3 个月内参加过或正在参加其他临床试验者；
8.筛选前 3 个月内献血包括成分血或大量失血（≥400mL），接受输血或使用血制品者；或打算在试验期间或试验结束后 3 个月内献血（包括血液成份）者；
9.筛选前14天内使用过任何处方药、非处方药、中草药和维生素者；
10.给药前1个月内服用了任何改变肝酶活性的药物或与氨氯地平存在相互作用的药物；
11.筛选前3个月内接种过疫苗者，或计划在试验期间接种疫苗者；
12.筛选前3个月内每日吸烟量大于5支，或试验期间不能停止使用任何烟草类产品者；
13.筛选前3个月内酒精摄入量平均每天超过2个单位（1单位=360mL啤酒，或150mL红酒，或45mL蒸馏酒），或酒精测试阳性者，或不同意在试验期间避免饮酒者；
14.在筛选前3个月内每天饮用过量浓茶、咖啡和/或含咖啡因的饮料（8杯以上，1杯=250mL）；
15.在服药前48h内摄取过浓茶、巧克力、咖啡或含咖啡因、含酒精、含黄嘌呤（如凤尾鱼、沙丁鱼、牛肝、牛肾等）、葡萄柚（汁）或西柚（汁）、橙子、火龙果、芒果、酸橙、杨桃的食物或饮料者；
16.对饮食有特殊要求，不能接受统一饮食者（如不能耐受牛奶、鸡蛋、黄油、培根等食物）者；
17.体格检查、生命体征检查异常且由临床医师判断为有临床意义者；
18.实验室检查（血常规、尿干化学+尿沉渣定量、血生化、凝血功能）、12-导联心电图检查异常并经临床医师判断有临床意义者；
19.乙肝病毒表面抗原、丙肝病毒抗体、HIV抗体（Anti-HIV）、梅毒螺旋体抗体任何一项或多项检查结果为阳性者；
20.女性处在妊娠期、哺乳期，或女性在计划给药前14天内有未保护性行为或血妊娠检查结果阳性者；
21.女性筛选前 6 个月内使用过长效雌激素和/或孕激素注射剂和/或埋植片或筛选前 30 天内使用过口服避孕药者；
22.在研究前筛选阶段或研究用药前发生急性疾病者；
23.其他研究者判定不适宜参加本项临床研究的受试者。

Exclusion criteria：

1.People who are allergic to amlodipine or pharmaceutical excipiants (such as lactose), or are known to be allergic to any drug or food, or have a history of specific allergic reactions (such as asthma, rubella, eczema dermatitis) or are severely allergic, and are judged by the investigator to be clinically significant;
2.Have a history of dysphagia or any gastrointestinal disorder that affects drug absorption;
3.A history of any chronic or serious disease of the circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental or metabolic abnormalities, or any other disease that may interfere with the results of the test, or a history of surgery within 3 months;
4.Have any medical condition that increases the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, and have a history of active pathological bleeding or intracranial bleeding;
5.Poor vascular puncture conditions, or can not tolerate venipuncture, or have a history of fainting needles and fainting blood;
6.A history of drug abuse in the six months prior to screening, or use of drugs in the three months prior to screening, including repeated, heavy use of narcotic drugs and psychotropic substances for non-medical purposes, Or urine addictive drugs morphine, methamphetamine (methamphetamine), ketamine, dimethylene dioxyamphetamine (ecstasy), tetrahydrocannabinol (cannabis) screening test any one or more positive results;
7.Participants who had enrolled or were enrolled in another clinical trial within 3 months before screening;
8.Blood donation within 3 months before screening included blood components, massive blood loss (≥400mL), transfusion or use of blood products; Or those who plan to donate blood (including blood components) during or within 3 months after the trial;
9.Use of prescription drugs, over-the-counter drugs, herbal medicines and vitamins within 14 days before screening;
10.Taking any drugs that alter liver enzyme activity or interact with amlodipine within 1 month before dosing;
11.Persons who were vaccinated within 3 months before screening or who were planning to be vaccinated during the trial;
12.Who smoked more than 5 cigarettes per day in the 3 months before screening, or who were unable to stop using any tobacco products during the trial;
13.Participants who consumed an average of more than 2 units of alcohol per day (1 unit =360 ml of beer, or 150 ml of red wine, or 45mL of distilled spirits) in the 3 months before screening, had a positive alcohol test, or did not agree to avoid alcohol during the trial;
14.Consuming excessive amounts of strong tea, coffee, and/or caffeinated beverages per day (> 8 cups, 1 cup =250mL) in the 3 months before screening;
15.People who have consumed strong tea, chocolate, coffee or foods or drinks containing caffeine, alcohol, xanthine (such as anchovies, sardines, beef liver, beef kidney, etc.), grapefruit (juice) or grapefruit (juice), orange, dragon fruit, mango, lime or star fruit within 48 hours before taking the drug;
16.Those who have special requirements for diet and cannot accept a uniform diet (such as intolerant to milk, eggs, butter, bacon and other foods);
17.Those with abnormal physical examination and vital signs judged by clinicians as clinically significant;
18.If laboratory tests (blood routine, urine dry chemistry and urine sediment quantification, blood biochemistry, coagulation function) and 12-lead electrocardiogram were abnormal and judged by clinicians to be clinically significant;
19.If any one or more tests of hepatitis B virus surface antigen, hepatitis C virus antibody, HIV antibody (Anti-HIV), and treponema pallidum antibody were positive;
20.Women who are pregnant, lactating, or who have had unprotected sex or a positive blood pregnancy test within 14 days before planned dosing;
21.Use of long-acting estrogen and/or progestin injections and/or implants within 6 months before screening or oral contraceptives within 30 days before screening;
22.Acute illness during pre-study screening or before study medication;
23.Participants who were judged by other investigators to be ineligible for participation in the study.

研究实施时间：

Study execute time：

从 From 2024-08-28 00:00:00至 To 2025-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-08-29 00:00:00 至 To 2024-09-02 00:00:00

干预措施：

Interventions：

组别：

R-T组（空腹）

样本量：

 13

Group：

R-T group(fasting)

Sample size：

干预措施：

第一周期受试者空腹口服参比制剂（R）10mg（1片），7天后受试者空腹口服受试制剂（T）5mg（1片）。

干预措施代码：

Intervention：

In the first cycle, the subjects took the reference formulation (R) 10mg(1 tablet) orally while fasting, and after 7 days, the subjects took the test formulation (T) 5mg(1 tablet) orally while fasting.

Intervention code：

组别：

R-T组（餐后）

样本量：

 13

Group：

R-T group(after meals)

Sample size：

干预措施：

第一周期受试者空腹口服参比制剂（R）10mg（1片），7天后受试者空腹口服受试制剂（T）5mg（1片）。

干预措施代码：

Intervention：

In the first cycle, the subjects took the reference formulation (R) 10mg(1 tablet) orally while fasting, and after 7 days, the subjects took the test formulation (T) 5mg(1 tablet) orally while fasting.

Intervention code：

组别：

T-R组（空腹）

样本量：

 13

Group：

T-R group (fasting)

Sample size：

干预措施：

第一周期受试者空腹口服受试制剂（T）5mg（1片），7天后受试者空腹口服参比制剂（R）10mg（1片）。

干预措施代码：

Intervention：

Taking investigational drugs

Intervention code：

组别：

T-R组（餐后）

样本量：

 13

Group：

T-R group (after meals)

Sample size：

干预措施：

第一周期受试者空腹口服受试制剂（T）5mg（1片），7天后受试者空腹口服参比制剂（R）10mg（1片）。

干预措施代码：

Intervention：

In the first cycle, the subjects took the test formulation (T) 5mg (1 tablet) orally while fasting, and after 7 days, the subjects took the reference formulation (R) 10mg (1 tablet) orally while fasting.

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：

峰浓度

指标类型：

主要指标

Outcome：

Cmax

Type：

Primary indicator

测量时间点：

2周期血样采集后

测量方法：

采用LC-MS/MS法测定

Measure time point of outcome：

After 2 cycles of blood sample collection

Measure method：

Determination using LC-MS/MS method

指标中文名：

从给药到给药后72h的曲线下面积

指标类型：

主要指标

Outcome：

AUC0-72hr

Type：

Primary indicator

测量时间点：

2周期血样采集后

测量方法：

采用LC-MS/MS法测定

Measure time point of outcome：

After 2 cycles of blood sample collection

Measure method：

Determination using LC-MS/MS 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

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 55 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）：

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。

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

Randomization schedules were generated by the statistical unit with the use of block randomization in SAS (version 9.4 or higher).

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）：

论文发表后一年内，国家生物信息中心 https://ngdc.cncb.ac.cn/gsa

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

Within one year of publication, China Nation center for Bioinformation https://ngdc.cncb.ac.cn/gsa.

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：

  2025-09-24 11:54:39