ChiCTR2200065975 版本V1.2 版本创建时间2023/05/03 22:12:48 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：

 ChiCTR2200065975 

最近更新日期：

Date of Last Refreshed on：

 2023-05-03 22:07:16 

注册时间：

Date of Registration：

 2022-11-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

恩格列净片人体生物等效性研究

Public title：

Bioequivalence study of empagliflozin tablets

注册题目简写：

English Acronym：

研究课题的正式科学名称：

恩格列净片在中国健康受试者中的单次给药、随机、 开放、两周期、双交叉、空腹与餐后状态下的生物等效性研究

Scientific title：

Single-dose, randomized, randomized and control study of empagliflozin tablets in healthy Chinese subjects Bioequivalence study in open, two-cycle, double-crossover, fasting and postprandial states

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：

张蕊 

研究负责人：

师少军 

Applicant：

Rui Zhang 

Study leader：

Shaojun Shi 

申请注册联系人电话：

Applicant telephone：

 +86 15527272759

研究负责人电话：

Study leader's
telephone：

+86 13871312811

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：

 392519821@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 sjshicn@163.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：

湖北省武汉市解放大道1277号

研究负责人通讯地址：

湖北省武汉市解放大道1277号

Applicant address：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei

Study leader's address：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei

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：

华中科技大学同济医学院附属协和医院

Applicant's institution：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究负责人所在单位：

华中科技大学同济医学院附属协和医院

Affiliation of the Leader：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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：

 [2022]伦审字（0661-01）号

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：

华中科技大学药物临床试验伦理委员会

Name of the ethic committee：

Ethics Committee of Huazhong University of Science and Technology Drug Clinical Trials

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-09-27 00:00:00

伦理委员会联系人：

褚圆圆

Contact Name of the ethic committee：

Yuanyuan Chu

伦理委员会联系地址：

湖北省武汉市解放大道1277号 协和医院药学楼6楼伦理办公室

Contact Address of the ethic committee：

6th Floor, Pharmaceutical Sciences Building, Union Hospital, 1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 27 85726375

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：

华中科技大学同济医学院附属协和医院

Primary sponsor：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究实施负责（组长）单位地址：

湖北省武汉市解放大道1277号

Primary sponsor's address：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北省

市(区县)：

武汉市

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

华中科技大学同济医学院附属协和医院

具体地址：

解放大道1277号

Institution
hospital：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Address：

1277 Jiefang Avenue, Jianghan District

经费或物资来源：

山东新时代药业有限公司

Source(s) of funding：

Shandong New Times Pharmaceutical Co., Ltd.

研究疾病：

不适用  

Target disease：

Not applicable

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：

 I期临床试验 

Study phase：

1

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

以山东新时代药业有限公司研制的恩格列净片（规格：10mg）为受试制剂，Boehringer Ingelheim International GmbH 持证的恩格列净片（Jardiance（欧唐静），规格：10mg）为参比制剂，考察两制剂在空腹及餐后状态下单次给药吸收速度和程度的差异，评价两制剂是否具有生物等效性。  

Objectives of Study：

The test preparation is Engellijing tablets (specification: 10 mg) developed by Shandong New Era Pharmaceutical Co., Ltd., and the licensed Engellijing tablets (Jardiance) of BoehringerIngelheim International GmbH (Ou Tangjing）Specification: 10 mg) is the reference preparation. The difference in absorption rate and degree of single administration between the two preparations under fasting and postprandial conditions is investigated to evaluate whether the two preparations are bioequivalent.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

受试者必须满足以下所有入选标准，方可入组本研究：
1.自愿参加并签署知情同意书；
2.健康男性或女性；
3.年龄18周岁及以上；
4.女性体重≥45.0kg，男性体重≥50.0kg，体重指数（BMI）=体重（kg）/身高2（m2），体重指数在19.0-26.0kg/m2，包含临界值。

Inclusion criteria

Subjects must meet all the following inclusion criteria before they can be included in this study: 1) voluntarily participate and sign the informed consent form; 2) Healthy male or female; 3) Age 18 years and above; 4) Female weight ≥ 45.0kg, male weight ≥ 50.0kg, body mass index (BMI)=weight (kg) /height 2 (m2), body mass index is 19.0-26.0kg/m2, including the critical value.

排除标准：

受试者符合以下任何一项排除标准，则不能入组本研究：
1.全身体检及血常规、血生化、尿常规、12导联心电图、病毒学检查、凝血功能检查等异常且具有临床意义者；
2.有严重心、肺、肝、肾、血液、胃肠、内分泌、免疫、皮肤病、神经或精神疾病等病史或现有上述疾病，经研究者判断不适合参加本研究者；
3.收缩压<90mmHg或舒张压<60mmHg，既往发生过体位性低血压者；
4.筛选前3个月内出现重大创伤或出血病史者；
5.近5年内有药物滥用史者或药筛检测阳性者；
6.有特定过敏史者（哮喘、荨麻疹、湿疹等），或过敏体质（如对两种或以上药物、食物如牛奶和花粉过敏者），或已知对本药组分或类似物过敏者；
7.采血困难或晕针、晕血或不能耐受静脉穿刺者；
8.酒精呼气检测结果不为0mg/100mL者；
9.筛选前3个月内酗酒（每周喝酒超过14单位酒精：1单位=啤酒约285mL，或烈酒约25mL，或葡萄酒约100mL）者或不同意试验期间戒酒者；
10.筛选前3个月内饮用过量茶、咖啡或含咖啡因的饮料者（一天8杯以上，1杯=250mL），或在服用研究药物前48小时内摄入任何含有酒精、咖啡因、或富含黄嘌呤的食物或饮料（如咖啡、浓茶、巧克力、可乐、西柚等）者；
11.不能遵守统一饮食，如对标准餐食物不耐受、乳糖不耐受（如喝牛奶腹泻）或吞咽困难者；
12.筛选前3个月内每日吸烟量≥5支者或试验期间不同意戒烟者；
13.筛选前14天内使用过任何药物者（包括处方药、非处方药、中草药、保健品）；
14.首次服用研究药物前30天内使用过任何抑制或诱导肝脏对药物代谢的药物（如：诱导剂—巴比妥类、卡马西平、苯妥英钠、利福平等；抑制剂-SSRI类抗抑郁药、西咪替丁、环孢素、大环内酯类、维拉帕米、喹诺酮类、吡咯类抗真菌药、HIV蛋白酶抑制剂等）者；
15.筛选前14天内或计划试验期间接种疫苗者；
16.筛选前3个月使用了任何临床试验药物或入组了任何药物临床试验者；
17.筛选前3个月内献血或其他原因出血导致失血总和≥400mL者（女性生理性失血除外）；
18.妊娠或者哺乳期妇女以及男性受试者（或其伴侣）或女性受试者在筛选前3周至试验结束后3个月内有妊娠计划，试验期间不愿采用一种医学认可的非药物避孕措施（如宫内节育器或避孕套）者；
19.研究者认为不适合入组的其他受试者。

Exclusion criteria：

Subjects who met any of the following exclusion criteria could not be included in this study: 1) those with clinical significance and abnormal physical examination, blood routine examination, blood biochemistry, urine routine examination, 12 lead ECG, virological examination, blood coagulation function examination, etc; 2) Severe heart, lung, liver, kidney, blood, gastrointestinal, endocrine, immune, skin Patients with disease, nervous or mental disease or other medical history or existing above diseases are not suitable for this study according to the judgment of the researcher; 3) Systolic blood pressure<90mmHg or diastolic blood pressure<60mmHg, who has had postural hypotension in the past; 4) Those with a history of major trauma or hemorrhagic disease within 3 months before screening; 5) Those with drug abuse history or positive drug screening test in recent 5 years; 6) People with specific allergic history (asthma, urticaria, eczema, etc.), or allergic constitution (such as those who are allergic to two or more drugs, food, such as milk and pollen), or those who are known to be allergic to the components or analogues of this drug; 7) Difficulty in blood collection or needle fainting, blood fainting or intolerance to venipuncture; 8) Alcohol breath test result is not 0mg /100mL; 9) Those who drink too much alcohol (more than 14 units of alcohol per week: 1 unit=about 285mL of beer, or about 25mL of spirits, or about 100mL of wine) within 3 months before screening or do not agree to abstain from alcohol during the trial; 10) Those who drank excessive tea, coffee or caffeinated drinks within 3 months before screening (more than 8 cups a day, 1 cup=250mL), or took any food or drink containing alcohol, caffeine or xanthine (such as coffee, strong tea, chocolate, cola, grapefruit, etc.) within 48 hours before taking the study drug; 11) Those who cannot follow the unified diet, such as intolerance to standard meal food, lactose intolerance (such as diarrhea after drinking milk) or dysphagia; 12) Those who smoked ≥ 5 cigarettes a day within 3 months before screening or those who did not agree to quit smoking during the trial; 13) Those who have used any drugs within 14 days before screening (including prescription drugs, over-the-counter drugs, Chinese herbal medicine and health care products); 14) Those who have used any drugs that inhibit or induce the metabolism of drugs in the liver within 30 days before taking the study drug for the first time (such as inducers - barbiturates, carbamazepine, phenytoin sodium, rifampicin; inhibitors - SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole antifungal drugs, HIV protease inhibitors, etc.); 15) Those vaccinated within 14 days before screening or during the planned trial; 16) Those who used any clinical trial drug or enrolled in any drug clinical trial 3 months before screening;17) Total blood loss ≥ 400mL due to blood donation or bleeding from other reasons within 3 months before screening (except female physiological blood loss); 18) Pregnant or lactating women and male subjects (or their partners) or female subjects have pregnancy plans from 3 weeks before screening to 3 months after the end of the trial, and are unwilling to use a medically recognized non drug contraceptive measure (such as intrauterine device or condom) during the trial; 19) Other subjects considered unsuitable by the researcher.

研究实施时间：

Study execute time：

从 From 2022-12-01 00:00:00至 To 2022-12-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-12-01 00:00:00 至 To 2022-12-10 00:00:00

干预措施：

Interventions：

组别：

空腹-T-R组

样本量：

 14

Group：

Fasting T-R group

Sample size：

干预措施：

受试者服药前至少禁食过夜 10h。给药当天早晨采集空白血样后，空腹口服受试制剂。第二周期口服参比试剂。

干预措施代码：

Intervention：

Subjects fasted overnight for at least 10 hours before taking the drug. After a blank blood sample was collected in the morning of the administration day, the test preparation was orally administered on an empty stomach. Oral reference reagent for the second cycle.

Intervention code：

组别：

空腹-R-T组

样本量：

 14

Group：

Fasting R-T group

Sample size：

干预措施：

受试者服药前至少禁食过夜 10h。给药当天早晨采集空白血样后，空腹口服参比制剂。第二周期口服受试试剂。

干预措施代码：

Intervention：

Subjects fasted overnight for at least 10 hours before taking the drug. After a blank blood sample was collected in the morning of the administration day, the reference preparation was taken orally on an empty stomach. The second cycle of oral test agents.

Intervention code：

组别：

高脂餐后-T-R组

样本量：

 14

Group：

High-fat postprandial T-R group

Sample size：

干预措施：

受试者服药前至少禁食过夜 10h。给药当天早晨采集空白血样后，高脂餐后口服受试制剂。第二周期口服参比试剂。

干预措施代码：

Intervention：

Subjects fasted overnight for at least 10 hours before taking the drug. After a blank blood sample was collected in the morning on the day of administration, the test preparation was orally administered after a high-fat meal. Oral reference reagent for the second cycle.

Intervention code：

组别：

高脂餐后-R-T组

样本量：

 14

Group：

High-fat postprandial R-T group

Sample size：

干预措施：

受试者服药前至少禁食过夜 10h。给药当天早晨采集空白血样后，高脂餐后口服参比制剂。第二周期口服受试试剂。

干预措施代码：

Intervention：

Subjects fasted overnight for at least 10 hours before taking the drug. After a blank blood sample was collected in the morning on the day of administration, the reference preparation was orally administered after a high-fat meal. The second cycle of oral test agents.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北 

市(区县)：

 武汉 

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

 华中科技大学同济医学院附属协和医院 

单位级别：

 三级甲等 

Institution
hospital：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血浆中恩格列净的血药浓度

指标类型：

主要指标

Outcome：

Plasma concentrations of empagliflozin in plasma

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

 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）：

随机表由统计单元采用SAS 9.4（或以上）软件按1：1分组随机生成，空腹试验和餐后试验随机化。

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

The random table was randomly generated by the statistical unit using SAS 9.4 (or above) software according to the 1:1 block, and the fasting test and the postprandial test were randomized.

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）：

不适用

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

NA

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：

不适用

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

NA

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-11-21 10:46:24