ChiCTR2500099997 版本V1.0 版本创建时间2025/04/01 15:56:01 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：

 ChiCTR2500099997 

最近更新日期：

Date of Last Refreshed on：

 2025-04-01 15:55:54 

注册时间：

Date of Registration：

 2025-04-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

美阿沙坦钾片人体生物等效性研究

Public title：

Bioequivalence study of losartan potassium tablets in humans

注册题目简写：

English Acronym：

研究课题的正式科学名称：

美阿沙坦钾片人体生物等效性研究

Scientific title：

Bioequivalence study of losartan potassium tablets in humans

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：

梁海秋 

研究负责人：

梁海秋 

Applicant：

Liang Haiqiu 

Study leader：

Liang Haiqiu 

申请注册联系人电话：

Applicant telephone：

 +86 13762810913

研究负责人电话：

Study leader's
telephone：

+86 738 8611061

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：

 258657959@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 258657959@qq.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：

湖南省娄底市娄星区碧溪路娄底市第一人民医院

研究负责人通讯地址：

湖南省娄底市娄星区碧溪路娄底市第一人民医院

Applicant address：

The First People's Hospital of Loudi City, Bixi Road, Louxing District, Loudi City, Hunan Province

Study leader's address：

The First People's Hospital of Loudi City, Bixi Road, Louxing District, Loudi City, Hunan Province

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：

娄底市第一人民医院

Applicant's institution：

The First People's Hospital of Loudi City

研究负责人所在单位：

娄底市第一人民医院

Affiliation of the Leader：

The First People's Hospital of Loudi City

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：

 会娄底市第一人民 YYLL-202502-Y4

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：

娄底市第一人民医院医学伦理委员会

Name of the ethic committee：

Loudi City First People's Hospital Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-02-25 00:00:00

伦理委员会联系人：

李建钢

Contact Name of the ethic committee：

Li Jiangang

伦理委员会联系地址：

娄底市娄星区碧溪路

Contact Address of the ethic committee：

Loudi Louxing District

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 738 8662980

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 18373879108@163.com

研究实施负责（组长）单位：

娄底市第一人民医院

Primary sponsor：

The first peoples hospital of loudi

研究实施负责（组长）单位地址：

娄底市娄星区碧溪路

Primary sponsor's address：

Loudi Louxing District

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南省

市(区县)：

Country：

China

Province：

Hunan Province

City：

单位(医院)：

娄底市第一人民医院

具体地址：

娄底市娄星区碧溪路

Institution
hospital：

The first peoples hospital of loudi

Address：

Loudi Louxing District

经费或物资来源：

长沙都正生物科技股份有限公司

Source(s) of funding：

Changsha Duzheng Biotechnology Co., Ltd

研究疾病：

无  

Target disease：

None

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：

本试验旨在研究单次空腹和餐后口服江苏天士力帝益药业有限公司研制、生产的美阿沙坦钾片（80 mg）的药代动力学特征；以Takeda Pharma A/S持证、Takeda Ireland Ltd.生产的美阿沙坦钾片（易达比?，80 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。  

Objectives of Study：

This trial aimed to study the pharmacokinetic characteristics of a single fasting and postprandial oral dose of 80 mg of the drug of MASATAN Potassium Tablets developed and manufactured by Jiangsu TASUN Group Diyi Pharmaceutical Co., Ltd.; and to compare the parameters Cmax, AUC0-t, AUC0-∞ of the two formulations, to evaluate the bioequivalence of the two formulations in the human.

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.年龄>=18周岁，健康研究参与者，男女均可； 2.男性研究参与者的体重>=50.0 kg，女性研究参与者的体重>=45.0 kg，体重指数（BMI）在18.5~30.0 kg/m^2之间（含边界值）； 3.研究参与者自愿签署书面的知情同意书。

Inclusion criteria

1. Age>=18 years old, health study participants, male or female; 2. The weight of male study participants >=50.0 kg, the weight of female study participants >=45.0 kg, and the body mass index (BMI) is between 18.5~30.0 kg/m^2 (including boundary values); 3. Study participants voluntarily signed written informed consent.

排除标准：

1.（问诊）既往或目前正患有循环系统、内分泌系统、神经系统、消化系统、呼吸系统、血液学、免疫学、精神病学及代谢异常等任何临床严重疾病或能干扰试验结果的任何其他疾病（如：低血压、高钾血症、主动脉瓣和二尖瓣狭窄、梗阻性肥厚型心肌病、肾动脉狭窄、原发性醛固酮增多症、肝功能损伤、肾功能损伤、有严重出血倾向等）者； 2.（问诊）有乳糖不耐受（如喝牛奶后腹泻）者； 3.（问诊）试验期间有驾驶车辆和操作机器要求者； 4.（问诊）对3种及以上物质有过敏史，或对本品中任何成分过敏者； 5.（问诊）首次服用研究药物前28天内接受过手术，或计划在试验期间进行手术者； 6.（问诊）首次服用研究药物前14天内使用过任何药物或保健品（包括中草药）者； 7.首次服用研究药物前3个月内使用了任何临床试验药物或入组了任何药物/医疗器械临床试验者； 8.（问诊）首次服用研究药物前3个月内献血者，或首次服用研究药物前3个月内失血超过400 mL者； 9.（问诊）不能忍受静脉穿刺和/或有晕血、晕针史者； 10.（问诊）首次服用研究药物前30天内使用过口服避孕药者，或首次服用研究药物前6个月内使用过长效雌激素或孕激素注射剂或埋植剂者； 11.（问诊）首次服用研究药物前14天内有过无保护性行为者（女性），或妊娠期或哺乳期女性； 12.（问诊）试验期间不能采取1种或以上非药物避孕措施者，或试验结束后6个月内有生育计划或捐精/捐卵计划者； 13.（问诊）对饮食有特殊要求，不能遵守统一饮食者； 14.（问诊）吞咽困难者； 15.（问诊）首次服用研究药物前3个月内每天饮用过量茶、咖啡或含咖啡因的饮料（8杯以上，1杯=250 mL）者； 16.（问诊）首次服用研究药物前48小时内，摄入过或计划摄入任何含有咖啡因的食物或饮料（如咖啡、浓茶、巧克力等）或富含黄嘌呤成分的食物（如沙丁鱼、动物肝脏等）或饮料者； 17.（问诊）首次服用研究药物前14天内摄入过或计划摄入葡萄柚或葡萄柚相关的柑橘类水果（如酸橙、柚子）、杨桃、木瓜、石榴或以上水果制品者； 18.（问诊）嗜烟者或首次服用研究药物前3个月内每日吸烟量多于5支者； 19.（问诊）酗酒者或首次服用研究药物前6个月内经常饮酒者，即每周饮酒超过14单位酒精（1单位≈200?mL酒精含量为5%的啤酒或25?mL酒精含量为40%的烈酒或85?mL酒精含量为12%的葡萄酒）； 20.（问诊）首次服用研究药物前7天内排便不规律者； 21.生命体征、体格检查、心电图、实验室检查等研究医生判断异常有临床意义，且经评估参加本试验将增加安全性风险者； 22.酒精测试不合格或滥用药物筛查阳性者； 23.可能因为其他原因不能完成本试验或研究者认为不应纳入者。

Exclusion criteria：

1. (Inquiry) Those who have suffered or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities or any other diseases that can interfere with the test results (such as: hypotension, hyperkalemia, aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy, renal artery stenosis, primary aldosteronism, liver damage, renal function damage, severe bleeding tendency, etc.); 2. (Inquiry) Lactose intolerance (such as diarrhea after drinking milk); 3. (Inquiry) Those who have the requirement to drive a vehicle and operate a machine during the test; 4. (Inquiry) Those who have a history of allergy to 3 or more substances, or are allergic to any of the ingredients in this product; 5. (Consultation) Those who have undergone surgery within 28 days before taking the study drug for the first time, or plan to undergo surgery during the trial; 6. (Consultation) Those who have used any drugs or health products (including Chinese herbal medicines) within 14 days before taking the study drug for the first time; 7. Those who have used any clinical trial drug or enrolled in any drug/medical device clinical trial within 3 months before taking the study drug for the first time; 8. (Inquiry) Those who donate blood within 3 months before taking the first dose of the study drug, or those who have lost more than 400 mL of blood within 3 months before the first dose of the study drug; 9. (Inquiry) Those who cannot tolerate venipuncture and/or have a history of blood sickness and needle sickness; 10. (Inquiry) Those who have used oral contraceptives within 30 days before taking the study drug for the first time, or those who have used long-acting estrogen or progestogen injections or implants within 6 months before taking the study drug for the first time; 11. (Consultation) Those who have had unprotected sex within 14 days before taking the study drug for the first time (female), or pregnant or lactating female; 12. (Inquiry) Those who cannot take one or more non-drug contraceptive measures during the test, or those who have a birth plan or sperm donation/egg donation plan within 6 months after the end of the test; 13. (Consultation) Those who have special requirements for diet and cannot comply with the uniform diet; 14. (Inquiry) Dysphagia; 15. (Inquiry) Those who drank excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months before taking the study drug for the first time; 16. (Inquiry) Within 48 hours before taking the study drug for the first time, those who have ingested or plan to ingest any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) or food rich in xanthine (such as sardines, animal liver, etc.) or drink; 17. (Inquiry) Those who have ingested or plan to ingest grapefruit or grapefruit-related citrus fruits (such as lime, grapefruit), star fruit, papaya, pomegranate or above fruit products within 14 days before taking the study drug for the first time; 18. (Inquiry) Smokers or those who smoke more than 5 cigarettes per day within 3 months before taking the study drug for the first time; 19. (Questioning) Alcoholics or regular drinkers within 6 months prior to the first dose of study drug, i.e., drinking more than 14 units of alcohol per week (1 unit ≈ 200 mL of beer with 5% alcohol or 25 mL of spirits with 40% alcohol or 85 mL of wine with 12% alcohol); 20. (Inquiry) Those who have irregular bowel movements within 7 days before taking the study drug for the first time; 21. Those who have clinical significance in the judgment of the research doctor on vital signs, physical examinations, electrocardiograms, laboratory examinations, etc., and those who are assessed to participate in this trial will increase the safety risk; 22. Those who fail to pass the alcohol test or have a positive drug abuse screen; 23. Those who may not be able to complete this trial for other reasons or who should not be included in the opinion of the investigator.

研究实施时间：

Study execute time：

从 From 2025-04-01 00:00:00至 To 2026-03-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-04-01 00:00:00 至 To 2026-03-30 00:00:00

干预措施：

Interventions：

组别：

空腹及餐后Ⅱ组

样本量：

 32

Group：

Fasting and postprandial group II

Sample size：

干预措施：

第一周期:研究参与者于给药前1天(Day-1)入住I期临床试验研究中心，给药前禁食至少10小时。于给药当天早上单次空腹口服受试制剂(T，80mg)或参比制剂(R，80mg)，240mL常温水送服(药物需完整吞服)。给药前及给药后1小时内禁止饮水，给药4、10小时后进食标准午餐和晚餐(统一的清淡饮食)。分别于给药前(0h)及给药后0.5、1、1.5、2、2.5、3、3.5、4、4.5、5、5.5、6、7、8、10、12、24、48h(共19个)采集静脉血约3mL。于入住时、给药前(0h)及给药后1、2、4、12、24、48h测量生命体征，试验过程中记录不良事件和合并用药。 清洗期:7天。 第二周期:研究参与者于给药前1天(Day7)入住I期临床试验研究中心，给药当天均按随机方案分别服用另一种制剂，重复第一周期过程。

干预措施代码：

Intervention：

Cycle I: Study participants are admitted to a phase I clinical trial research center 1 day before dosing (Day-1) and fasted for at least 10 hours before dosing. On the morning of the day of administration, the test preparation (T, 80mg) or the reference preparation (R, 80mg) should be taken orally on an empty stomach and 240mL of room temperature water (the drug should be swallowed completely). It is forbidden to drink water before and within 1 hour after administration, and eat a standard lunch and dinner (a uniform light diet) 4 or 10 hours after administration. About 3mL of venous blood was collected before administration (0h) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 24, and 48h (a total of 19) after administration. Vital signs were measured at check-in, before dosing (0h) and at 1, 2, 4, 12, 24, and 48h after dosing, and adverse events and concomitant medications were recorded during the test. Washing period: 7 days. Second cycle: The study participants were admitted to the phase I clinical trial research center 1 day before dosing (Day7), and on the day of administration, they were given another preparation according to the randomized protocol, and the first cycle process was repeated.

Intervention code：

组别：

空腹及餐后Ⅰ组

样本量：

 32

Group：

Fasting and postprandial group I

Sample size：

干预措施：

第一周期:研究参与者于给药前1天(Day-1)入住I期临床试验研究中心，给药前禁食至少10小时(不包括高脂高热量餐)。于给药当天早上开始进食高脂高热量餐(蛋白质约提供150千卡热量、碳水化合物约提供250千卡热量、脂肪约提供500~600千卡热量，总热量约 800~1000千卡，其中约50%的热量来自于脂肪，餐后给药试验中两个试验周期应保证试验餐的配方一致)。高脂高热量餐后单次口服受试制剂(T，80mg)或参比制剂(R，80mg),240mL常温水送服(药物需完整吞服)。给药前完成高脂高热量餐进食，药物需在进餐后且以开始进餐时间计的30min(±1min)时服用。给药前及给药后1小时内禁止饮水，给药4、10小时后进食标准午餐和晚餐(统一的清淡饮食)。分别于给药前(0h)及给药后0.5、1、1.5、2、2.5、3、3.5、4、4.5、5、5.5、6、7、8、10、12、24、48h(共19个)采集静脉血约3mL。于入住时、给药前(0h)及给药后1、2、4、12、24、48h测量生命体征，试验过程中记录不良事件和合并用药。 清洗期:7天。 第二周期:研究参与者于给药前1天(Day7)入住I期临床试验研究中心，给药当天均按随机方案分别服用另一种制剂，重复第一周期过程。

干预措施代码：

Intervention：

Cycle I: Study participants are admitted to the phase I clinical trial research center 1 day before dosing (Day-1) and fasted for at least 10 hours before dosing (excluding high-fat and high-calorie meals). Start eating high-fat and high-calorie meals on the morning of the day of administration (protein provides about 150 kcal, carbohydrates provide about 250 kcal, fat provides about 500~600 kcal, total calories are about 800~1000 kcal, of which about 50% of the calories come from fat, and the formula of the test meal should be consistent in the two test cycles in the postprandial dosing test). High-fat and high-calorie after a meal, the test preparation (T, 80mg) or the reference preparation (R, 80mg) was taken orally at 240mL of room temperature water (the drug needs to be swallowed completely). Complete the high-fat and high-calorie meal before administration, and the drug should be taken after the meal and 30 minutes (± 1 minute) after the meal. It is forbidden to drink water before and within 1 hour after administration, and eat a standard lunch and dinner (a uniform light diet) 4 or 10 hours after administration. About 3mL of venous blood was collected before administration (0h) and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 12, 24, and 48h (a total of 19) after administration. Vital signs were measured at check-in, before dosing (0h) and at 1, 2, 4, 12, 24, and 48h after dosing, and adverse events and concomitant medications were recorded during the test. Washing period: 7 days. Second cycle: The study participants were admitted to the phase I clinical trial research center 1 day before dosing (Day7), and on the day of administration, they were given another preparation according to the randomized protocol, and the first cycle process was repeated.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

  

Country：

China

Province：

Hunan

City：

单位(医院)：

 娄底市第一人民医院 

单位级别：

 三级甲等 

Institution
hospital：

The first peoples hospital of loudi

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Cmax

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：

AUC0-t

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：

AUC0-∞

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：

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

 其它  

说明

Fate of sample：

0thers  

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 18 岁 years
最大 Max age 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）：

由程序员通过SAS软件随机

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

Randomized by programmers via SAS software

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

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）：

无

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

None

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

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

Electronic collection and management system

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-04-01 15:55:54