ChiCTR2100050603 版本V1.5 版本创建时间2022/05/01 23:54:03 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：

 ChiCTR2100050603 

最近更新日期：

Date of Last Refreshed on：

 2022-04-30 12:03:36 

注册时间：

Date of Registration：

 2021-09-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

奥美拉唑肠溶胶囊人体生物等效性预实验

Public title：

Bioequivalence of Omeprazole Enteric-Coated Capsules in the Healthy Human Body: A Randomized Cross-Over Controlled Pre-Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

奥美拉唑肠溶胶囊人体生物等效性预实验

Scientific title：

Bioequivalence of Omeprazole Enteric-Coated Capsules in the Healthy Human Body: A Randomized Cross-Over Controlled Pre-Trial

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：

黄建 

研究负责人：

张毕奎 

Applicant：

Huang Jian 

Study leader：

Zhang Bikui 

申请注册联系人电话：

Applicant telephone：

 +86 18867362978

研究负责人电话：

Study leader's
telephone：

+86 13973116871

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：

 cra2@csruiyi.com

研究负责人电子邮件：

Study leader's E-mail：

 bikui-zh@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：

长沙高新开发区麓谷大道627号

研究负责人通讯地址：

湖南省长沙市人民中路139号

Applicant address：

627 Lugu Avenue, High-Tech Development District, Changsha, Hu'nan

Study leader's address：

139 Renmin Middle Road, Changsha, Hu'nan, China

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：

长沙睿依医药科技有限公司

Applicant's institution：

Changsha Ruiyi Medical Technology Co. Ltd.

研究负责人所在单位：

Affiliation of the Leader：

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：

 伦审第（20210811-Y15）

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：

湘雅博爱康复医院伦理委员会

Name of the ethic committee：

Ethics Committee of Xiangya Boai Rehabilitation Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 1990-01-01 00:00:00

伦理委员会联系人：

彭甜

Contact Name of the ethic committee：

Peng Tian

伦理委员会联系地址：

中国湖南省长沙市万家丽北路61号

Contact Address of the ethic committee：

61 Wanjiali Road North, Changsha, Hu'nan, China

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：

湘雅博爱康复医院

Primary sponsor：

Xiangya Boai Rehabilitation Hospital

研究实施负责（组长）单位地址：

中国湖南省长沙市万家丽北路61号

Primary sponsor's address：

61 Wanjiali Road North, Changsha, Hu'nan, China

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

市(区县)：

长沙

Country：

China

Province：

Hu'nan

City：

Changsha

单位(医院)：

湘雅博爱康复医院

具体地址：

万家丽北路61号

Institution
hospital：

Xiangya Boai Rehabilitation Hospital

Address：

61 Wanjiali Road North

经费或物资来源：

香港正美药品有限公司

Source(s) of funding：

Hong Kong Zhengmei Pharmaceutical Co., Ltd.

研究疾病：

人体药代动力学与生物等效性  

Target disease：

Pharmacokinetics and Bioequivalence Study in human

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：

主要目的：分别采用单中心、随机、开放、三周期、半重复交叉、单剂量给药设计进行空腹和饱腹给药试验，评价香港正美药品有限公司生产的奥美拉唑肠溶胶囊在中国健康人群空腹和饱腹状态下口服后两制剂的生物等效性及安全性，为后期正式生物等效性试验方案设计提供参考。  

Objectives of Study：

Main purpose: To conduct fasting and satiety dosing trials in a single-center, randomized, open-label, three-cycle, semi-repetitive crossover, single-dose dosing design, respectively, to evaluate the efficacy of omeprazole enteric-coated capsules produced by Hong Kong Zhengmei Pharmaceutical Co., Ltd. in China The bioequivalence and safety of the two preparations after oral administration in healthy people on an empty stomach and a full stomach provide a reference for the design of a later formal bioequivalence test program.

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.年龄在18周岁以上（含18周岁）的中国健康受试者，男女兼有；
2.男性体重≥50 kg；女性体重≥45 kg；体重指数在19~26 kg/m2范围内（包括临界值）（体重指数（BMI）＝体重（kg）/身高2（m2））；
3.试验前签署知情同意书、并对试验内容、过程及可能出现的不良反应充分了解；
4.受试者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。

Inclusion criteria

1. Chinese healthy subjects over 18 years old (including 18 years old), both male and female;
2. Male weight >= 50 kg; female weight >= 45 kg; body mass index in the range of 19~26 kg/m2 (including the critical value) (body mass index (BMI) = weight (kg) / height 2 (m2));
3. Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions;
4. The subjects can communicate well with the researcher, and understand and comply with the requirements of this research.

排除标准：

1.试验前3个月内参加了任何临床试验者；
2.试验前3年内有消化道疾病（如胃炎、肠炎、习惯性腹泻或便秘，经常出现烧心、反酸或者上腹胀气，餐后恶心或嗳气等）或消化道手术且研究者认为目前仍有临床意义者；
3.既往曾有运动系统（如：骨折）、消化系统、呼吸系统、泌尿系统、生殖系统、内分泌系统、免疫系统、神经系统和循环系统等病史且研究者认为目前仍有临床意义者；
4.对奥美拉唑、其他苯并咪唑类或本品中任何其他成份过敏，或过敏体质者；
5.试验期间需要进行驾驶、高空作业和机械操作者；
6.对静脉穿刺不耐受或有晕血、晕针史者；
7.试验前6个月内接受过经研究者判断会影响药物吸收、分布、代谢、排泄的手术者；或试验前4周内接受过任何手术者；或计划在研究期间进行手术者；
8.试验前14天内使用过任何药物（包括中草药、维生素等）、保健品等者；
9.试验前30天内使用过甲氨蝶呤或任何抑制或诱导肝脏对药物代谢的药物（如圣-约翰草、利福平、卡马西平、氟康唑、伏立康唑、奈非那韦、利匹韦林、避孕药等）者；
10.试验前30天内接种过疫苗，或计划在试验期间接种疫苗者（包括减毒活疫苗和新冠疫苗）；
11.试验前3个月内献血或大量失血（>200 mL，女性生理期除外）者，或计划在试验期间或试验结束后3个月内献血者；
12.药物滥用者或试验前1年内使用过软毒品（如：大麻）或硬毒品（如：可卡因、苯环己哌啶等）者；
13.嗜烟者或试验前3个月内每日吸烟量多于5支者，或不同意试验期间停止使用任何烟草类产品者；
14.酗酒者或试验前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）；或不同意试验期间停止饮酒或任何含酒精的制品者；
15.每天饮用过量茶、咖啡和/或含咖啡因的饮料（8杯以上，1杯=250 mL）者，或不同意试验期间停止饮用茶、咖啡和/或含咖啡因的饮料者；
16.对饮食有特殊要求，不能遵守统一饮食者；
17.有半乳糖不耐症、Lapp乳糖酶缺乏症或葡萄糖-半乳糖吸收不良等罕见遗传病者；
18.试验前2周内发生非保护性性行为，受试者或其配偶（或其伴侣）在试验期间至试验结束后3个月内有妊娠计划、捐精捐卵计划，或不同意在试验期间采取一种或一种以上的非药物避孕措施（如完全禁欲、避孕环、伴侣结扎等）者；
19.妊娠期或哺乳期女性；
20.心电图、实验室检查、生命体征各项检查异常且有临床意义者；
21.受试者依从性差或可能因为其他原因而不能完成本研究或经研究者判断具有其它不宜参加试验原因者。
每周期入住期排除标准：
符合下列条件之一者也应排除：
(1)从上次离院至今，参加了除本试验以外的其他任何临床试验者；
(2)从上次离院至今，献血或大量失血（>200 mL，女性生理期除外）者；
(3)从上次离院至今，使用任何药物及保健品、吸烟、饮酒，或发生病史改变且研究者认为对本品吸收、分布、代谢、排泄有影响者；
(4)从上次离院至今，饮用茶、咖啡和/或含咖啡因的饮料且研究者认为对本品吸收、分布、代谢、排泄有影响者；
(5)从上次离院至今，进食可能影响药物体内代谢的饮食（包括火龙果、葡萄柚或葡萄柚产品、柚子、橘子、甘蓝类蔬菜、炭烤食物等），或研究者认为有其他影响药物吸收、分布、代谢、排泄的饮食者；
(6)从上次离院至今，接种过疫苗，或计划会在试验期间接种疫苗者（包括减毒活疫苗和新冠疫苗）；
(7)从上次离院至今，发生过非保护性性行为者；
(8)生命体征异常有临床意义且经研究者判断不适宜继续参加试验者；
(9)多项毒品联合检测（吗啡、冰毒、氯胺酮、摇头丸、大麻）结果呈阳性者；
(10)呼气酒精检测结果>0.0 mg/100 mL（阳性）者；
(11)血妊娠检查结果异常且具有临床意义者（限女性）；
(12)体格检查异常且具有临床意义者；（仅适用于第Ⅰ周期）
(13)受试者依从性差或可能因为其他原因而不能完成本研究或经研究者判断具有其它不宜参加试验原因者。

Exclusion criteria：

1. Those who participated in any clinical trial within 3 months before the trial;
2. Digestive tract disease (such as gastritis, enteritis, habitual diarrhea or constipation, frequent heartburn, acid regurgitation or epigastric bloating, postprandial nausea or belching, etc.) or digestive tract surgery within 3 years prior to the trial clinically significant;
3. Those who have a medical history of the motor system (such as fractures), digestive system, respiratory system, urinary system, reproductive system, endocrine system, immune system, nervous system and circulatory system in the past and the researchers believe that there is still clinical significance;
4. Those who are allergic to omeprazole, other benzimidazoles or any other ingredients in this product, or have allergic constitution;
5. Driving, aerial work and machinery operators are required during the test;
6. Those who are intolerant to venipuncture or have a history of fainting blood or acupuncture;
7. Those who have undergone surgery that, as judged by the investigator, will affect the absorption, distribution, metabolism, and excretion of drugs within 6 months before the trial; or who have undergone any surgery within 4 weeks before the trial; or those who plan to undergo surgery during the study;
8. Those who have used any drugs (including Chinese herbal medicines, vitamins, etc.), health products, etc. within 14 days before the test;
9. Use of methotrexate or any drug that inhibits or induces liver metabolism of drugs within 30 days before the test (such as St. John's wort, rifampicin, carbamazepine, fluconazole, voriconazole, nelfinavir, Pevirine, contraceptives, etc.);
10. Those who have been vaccinated within 30 days before the trial, or who plan to be vaccinated during the trial (including live attenuated vaccines and new crown vaccines);
11. Those who donated blood or lost a large amount of blood (>200 mL, except women's menstrual period) within 3 months before the trial, or those who plan to donate blood during the trial or within 3 months after the end of the trial;
12. Drug abusers or those who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the test;
13. Smokers or those who smoked more than 5 cigarettes per day within 3 months before the trial, or those who do not agree to stop using any tobacco products during the trial;
14. Alcoholics or frequent drinkers within 6 months prior to the trial, i.e. drinking 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); or disagree Those who stopped drinking alcohol or any alcoholic products during the trial;
15. Those who drink too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day, or those who do not agree to stop drinking tea, coffee and/or caffeinated beverages during the trial;
16. Those who have special requirements for diet and cannot comply with the unified diet;
17. Patients with rare genetic diseases such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;
18. Unprotected sexual behavior occurred within 2 weeks before the trial, and the subject or his spouse (or his partner) had a pregnancy plan, sperm donation and egg donation plan during the trial period to 3 months after the end of the trial, or did not agree to the Those who took one or more non-drug contraceptive measures (such as complete abstinence, contraceptive ring, partner sterilization, etc.) during the trial;
19. Women who are pregnant or breastfeeding;
20. Patients with abnormal electrocardiogram, laboratory examination, vital signs and clinical significance;
21. Subjects have poor compliance or may be unable to complete the study for other reasons or have other reasons judged by the investigator to be unsuitable to participate in the trial.
Exclusion criteria for each period of stay:
One of the following conditions should also be excluded:
(1) Those who have participated in any other clinical trials except this trial since the last time they were discharged from the hospital;
(2) Those who have donated blood or lost a large amount of blood (>200 mL, except women's menstrual period) since their last discharge from the hospital;
(3) Those who have used any drugs and health care products, smoked, or consumed alcohol, or had changes in their medical history since the last time they were discharged from the hospital, and the researchers believe that they have an impact on the absorption, distribution, metabolism, and excretion of this product;
(4) Those who have consumed tea, coffee and/or caffeinated beverages since the last time they were discharged from the hospital and the researchers believe that they have an impact on the absorption, distribution, metabolism and excretion of this product;
(5) Since the last discharge from the hospital, eating food that may affect the metabolism of drugs in the body (including dragon fruit, grapefruit or grapefruit products, grapefruit, oranges, cabbage vegetables, charcoal grilled food, etc.), or other foods that the researchers believe may affect the metabolism Dieters that affect drug absorption, distribution, metabolism, and excretion;
(6) Those who have been vaccinated or plan to be vaccinated during the trial (including live attenuated vaccines and new crown vaccines) since their last discharge from the hospital;
(7) Those who have had unprotected sex since the last time they were discharged from the hospital;
(8) Patients with abnormal vital signs that are clinically significant and judged by the investigator to be unsuitable to continue participating in the trial;
(9) Those with positive results of multiple drug joint tests (morphine, methamphetamine, ketamine, ecstasy, marijuana);
(10) Those with breath alcohol test result >0.0 mg/100 mL (positive);
(11) Those with abnormal and clinically significant blood pregnancy test results (limited to females);
(12) Abnormal physical examination and clinical significance; (only applicable to the first cycle)
(13) Subjects with poor compliance or may be unable to complete the study for other reasons or have other reasons judged by the investigator to be unsuitable to participate in the trial.

研究实施时间：

Study execute time：

从 From 2021-09-15 00:00:00至 To 2021-12-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-09-15 00:00:00 至 To 2021-09-20 00:00:00

干预措施：

Interventions：

组别：

试验组1

样本量：

 8

Group：

Experimental group1

Sample size：

干预措施：

第Ⅰ周期服用受试制剂， 第Ⅱ/Ⅲ周期服用参比制剂

干预措施代码：

Intervention：

The test preparation is taken in the first cycle, and the reference preparation is taken in the II/III cycle

Intervention code：

组别：

试验组2

样本量：

 8

Group：

Experimental group2

Sample size：

干预措施：

第Ⅰ/Ⅲ周期服用参比制剂，第Ⅱ周期服用 受试制剂

干预措施代码：

Intervention：

The reference preparation is taken in cycle I/III, and the test preparation is taken in cycle II

Intervention code：

组别：

试验组3

样本量：

 8

Group：

Experimental group3

Sample size：

干预措施：

第Ⅰ/Ⅱ周期服用参比制剂，第Ⅲ周期服用受试制剂

干预措施代码：

Intervention：

The reference preparation was taken in the I/II cycle, and the test preparation was taken in the third cycle

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：

Hu'nan

City：

单位(医院)：

 湘雅博爱康复医院 

单位级别：

 三级甲等 

Institution
hospital：

Xiangya Boai Rehabilitation Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血浆药物峰浓度

指标类型：

主要指标

Outcome：

Peak plasma drug concentration

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

0 h到12 h血药浓度-时间曲线下面积

指标类型：

主要指标

Outcome：

Area under the plasma concentration-time curve from 0 h to 12 h

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

0 h到无穷血药浓度-时间曲线下面积

指标类型：

主要指标

Outcome：

Area under the plasma concentration-time curve from 0 h to infinity

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：

次要指标

Outcome：

peak time

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：

Sample Name：

Blood

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：

尚未开始

Not yet 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）：

随机分组表采用SPSS 24.0生成

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

The random grouping table was generated by SPSS 24.0

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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)：

NO

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：

使用北京中兴正远科技有限公司的临床试验全过程数据采集管理系统

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

Data Collection and Management System：Beijing Zhongxing Zhengyuan Technology Co., Ltd

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-09-01 13:58:46