中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2200059708
最近更新日期： Date of Last Refreshed on：	2023-02-23 20:18:18
注册时间： Date of Registration：	2022-05-09 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	布洛芬颗粒生物等效性试验
Public title：	Bioequivalence test of ibuprofen granules
注册题目简写：
English Acronym：
研究课题的正式科学名称：	布洛芬颗粒（0.2g）在中国健康受试者中单次空腹与餐后用药，两制剂、两周期、两序列、随机、开放、自身交叉的生物等效性研究
Scientific title：	Pharmacokinetics, Bioequivalence and Safety Evaluation of 2 Formulations of Ibuprofen Granules 0.2g: A Randomized, Single Dose, Open-Label, 2-Preparation, 2-Sequence, 2-Period Crossover Study in Healthy Chinese Volunteers Under Fasting and Fed 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 13928808723	研究负责人电话： Study leader's telephone：	+86 13928808723
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：	广东省广州市番禺区桥南街福愉东路8号	研究负责人通讯地址：	广东省广州市番禺区桥南街福愉东路8号
Applicant address：	8 Fuyu Road East, Qiaonan Street, Panyu District, Guangzhou, Guangdong	Study leader's address：	8 Fuyu Road East, Qiaonan Street, Panyu District, Guangzhou, Guangdong
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：	广州市番禺区中心医院
Applicant's institution：	Guangzhou Panyu Central Hospital
研究负责人所在单位：	广州市番禺区中心医院
Affiliation of the Leader：	Guangzhou Panyu Central 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：	PYZXYYEC【2018】P051	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：	广州市番禺区中心医院药物临床试验伦理委员会
Name of the ethic committee：	Ethics Committee of Drug Clinical Trials, Panyu Central Hospital, Guangzhou
伦理委员会批准日期： Date of approved by ethic committee：	2018-08-01 00:00:00
伦理委员会联系人：	李泳桃
Contact Name of the ethic committee：	Li Yongtao
伦理委员会联系地址：	广州市番禺区福愉东路8号番禺区中心医院门诊一楼临床试验伦理委员会办公室
Contact Address of the ethic committee：	Clinical Trial Ethics Committee Office, 1st Floor, Outpatient Department, Panyu Central Hospital, 8 Fuyu Road East, Qiaonan Street, Panyu District, Guangzhou, Guangdong
伦理委员会联系人电话： Contact phone of the ethic committee：		伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

广州市番禺区中心医院

Primary sponsor：

Guangzhou Panyu Central Hospital

研究实施负责（组长）单位地址：

广东省广州市番禺区桥南街福愉东路8号

Primary sponsor's address：

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

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	市(区县)：	广州
Country：	China	Province：	Guangdong	City：	Guangzhou
单位(医院)：	广州市番禺区中心医院	具体地址：	番禺区桥南街福愉东路8号
Institution hospital：	Guangzhou Panyu Central Hospital	Address：	8 Fuyu Road East, Qiaonan Street, Panyu District

经费或物资来源：

申办方经费

Source(s) of funding：

Sponsor's funding

研究疾病：

发烧，疼痛，偏头痛和痛经

Target disease：

fever, pain, migraine and dysmenorrhoea

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：

本研究评估了布洛芬颗粒的参考制剂和试验制剂在单剂量给药后喂养和禁食条件下是否具有生物等效性，并评估了这两种配方的安全性。

Objectives of Study：

This study assessed whether the reference and test formulations of ibuprofen granules were bioequivalent under fed and fasting conditions postadministration of a single dose as well as evaluated the safety profile of these 2 formulations.

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

1. Chinese healthy male or female subjects, aged 18-45 (including 18 and 45);
2. Body mass index (BMI) = weight (kg)/height 2 (m2), body mass index within the range of 18.5-26.0 (including the critical value); male body weight >= 50 kg, female body weight >= 45 kg;
3. Health status: no history of chronic diseases or serious diseases such as cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immune, mental, nervous, and gastrointestinal systems;
4. Comprehensive physical examination, laboratory examination, abdominal B-ultrasound, and electrocardiogram all show normal or abnormal without clinical significance (subject to the investigator's judgment), and the investigator believes that the subject's health is in good condition;
5. Subjects must fully understand and voluntarily sign the informed consent form for this study;
6. The subjects or their partners must be willing to use medically acceptable contraceptive methods from the signing of the informed consent form to the end of the trial within 3 months, and the subjects cannot use contraception from the signing of the informed consent form to the end of the trial drug;
7. The subjects can communicate well with the researchers and complete the research according to the protocol.

排除标准：

1. 过敏体质或已知对布洛芬过敏；
2. 研究者认为具有临床上有意义的心血管、血液、肝、肾、内分泌、呼吸（特别是支气管哮喘）、消化（特别是溃疡病史）、神经、精神、免疫、皮肤及代谢紊乱等疾病或任何其他疾病或具有这些疾病的病史及症状，或将危害受试者的安全或影响研究结果的因素，或曾有过重大手术史；
3. 在试验前3个月内接受过手术，或者计划在试验期间进行手术者；
4. 乙肝表面抗原阳性，或丙肝抗体阳性，或梅毒检测阳性，或艾滋病病毒抗体检测阳性；
5. 妊娠期、哺乳期妇女，或育龄期妇女试验前血妊娠检查结果阳性者；
6. 女性受试者在给药前30天至研究结束后3个月内有妊娠计划；男性受试者及其伴侣在试验结束后3个月内有妊娠计划；
7. 具有药物滥用史或药物滥用筛查阳性；
8. 习惯性服用任何药物（包括中草药）或功能性维生素；
9. 筛选前14天内服用了任何处方药、非处方药、中草药等；
10. 筛选前3个月内每周饮用≥14个单位的酒精者：1单位=啤酒285ml，或烈酒25ml，或葡萄酒250mL；或筛选时酒精检测呈阳性，或试验期间不能中断饮酒者；
11. 筛选前 3 个月内嗜烟史（每天吸烟超过 5 支或等量的烟草）；
12. 习惯每天饮用过量的茶、咖啡和或含咖啡因的饮料（平均每天8杯以上，每杯200mL）者或试验期间不能中断；
13. 对饮食有特殊要求，不能遵守统一饮食（如对高脂饮食不耐受等）；
14. 筛选前3个月内参加过其它临床试验并服用其试验药物者，或正在参加其他临床试验者；
15. 筛选前3个月内献血或大量失血（≥200 mL）；
16. 不能耐受静脉穿刺，或有晕针晕血史者或静脉采血困难者；
17. 在试验前筛选阶段或试验用药前发生急性疾病者；
18. 研究者认为任何不适宜受试者进入本项试验的其它因素。

Exclusion criteria：

1. Allergic constitution or known allergy to ibuprofen;
2. The researchers believe that there are clinically significant cardiovascular, blood, liver, kidney, endocrine, respiratory (especially bronchial asthma), digestive (especially ulcer history), nervous, mental, immune, skin and metabolic disorders and other diseases or any other diseases or have the medical history and symptoms of these diseases, or factors that will endanger the safety of the subjects or affect the research results, or have had a history of major surgery;
3. Those who have undergone surgery within 3 months before the trial, or plan to undergo surgery during the trial;
4. Hepatitis B surface antigen positive, or hepatitis C antibody positive, or syphilis test positive, or HIV antibody test positive;
5. Pregnant, lactating women, or women of childbearing age who have a positive blood pregnancy test before the test;
6. Female subjects have pregnancy plans from 30 days before the administration to 3 months after the end of the study; male subjects and their partners have pregnancy plans within 3 months after the end of the test;
7. Have a history of drug abuse or a positive drug abuse screening;
8. Habitually taking any medicine (including Chinese herbal medicine) or functional vitamins;
9. Take any prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc. within 14 days before screening;
10. Those who drink >= 14 units of alcohol per week within 3 months before screening: 1 unit = 285 ml of beer, or 25 ml of spirits, or 250 ml of wine; or those who have a positive alcohol test at the time of screening, or those who cannot stop drinking during the test;
11. History of smoking within 3 months before screening (smoking more than 5 cigarettes or equivalent amount of tobacco per day);
12. People who are used to drinking excessive tea, coffee and or caffeinated beverages (average more than 8 cups per day, 200 mL per cup) or cannot be interrupted during the test;
13. Have special requirements for diet and cannot follow a unified diet (such as intolerance to high-fat diet, etc.);
14. Those who have participated in other clinical trials and taken their experimental drugs within 3 months before screening, or those who are participating in other clinical trials;
15. Blood donation or massive blood loss (>= 200 mL) within 3 months before screening;
16. Those who cannot tolerate venipuncture, or have a history of dizziness of needles and blood, or have difficulty in venous blood collection;
17. Patients with acute diseases during the pre-test screening stage or before the test drug;
18. Any other factors considered by the investigator to be inappropriate for the subject to enter this trial.

研究实施时间：

Study execute time：

从 From 2018-10-10 00:00:00至 To 2018-12-03 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2018-10-11 00:00:00 至 To 2018-11-20 00:00:00

干预措施：

Interventions：

组别：	A组	样本量：	24
Group：	Group A	Sample size：	24
干预措施：	餐后：第一周期给予受试制剂，第二周期给予参比制剂	干预措施代码：
Intervention：	After meals: the test formulation was given in the first phase, and reference formulation was given in the second phase	Intervention code：

组别：	B组	样本量：	24
Group：	Group B	Sample size：	24
干预措施：	餐后：第一周期给予参比制剂，第二周期给予受试制剂	干预措施代码：
Intervention：	After meals: the reference formulation was given in the first phase, and test formulation was given in the second phase	Intervention code：

组别：	C组	样本量：	12
Group：	Group C	Sample size：	12
干预措施：	空腹：第一周期给予受试制剂，第二周期给予参比制剂	干预措施代码：
Intervention：	Fasting: the test formulation was given in the first phase, and reference formulation was given in the second phase	Intervention code：

组别：	D组	样本量：	12
Group：	Group D	Sample size：	12
干预措施：	空腹：第一周期给予参比制剂，第二周期给予受试制剂	干预措施代码：
Intervention：	Fasting: the reference formulation was given in the first phase, and test formulation was given in the second phase	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东	市(区县)：	广州
Country：	China	Province：	Guangdong	City：	Guangzhou
单位(医院)：	广州市番禺区中心医院	单位级别：	三甲
Institution hospital：	Guangzhou Panyu Central Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	布洛芬的血液浓度	指标类型：	主要指标
Outcome：	Blood levels of ibuprofen	Type：	Primary indicator
测量时间点：		测量方法：	高相液相色谱/串联质谱联用法
Measure time point of outcome：		Measure method：	HPLC-MS/MS

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	45	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）：

由统计公司根据受试者筛选顺序在电子计算机上用SAS 9.3或以上版本产生随机表。

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

According to the screening order of the subjects, the statistical company will use SAS9.3 or above to generate a random table on the computer.

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）：	向研究者索要结果
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Ask the researchers for the results
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：	病历记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2022-05-09 09:38:11