ChiCTR2300071607 版本V1.1 版本创建时间2023/07/19 21:05:18 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：

ChiCTR2300071607 

最近更新日期：

Date of Last Refreshed on：

2023-05-19 09:34:34 

注册时间：

Date of Registration：

2023-05-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

卡格列净片随机、开放、两制剂、两周期、交叉、空腹及餐后给药健康人体生物等效性试验

Public title：

Randomized, open, two-formulation, two-cycle, crossover, fasting and postprandial administration bioequivalence trial in healthy humans of Cargolizine tablets

注册题目简写：

English Acronym：

研究课题的正式科学名称：

卡格列净片随机、开放、两制剂、两周期、交叉、空腹及餐后给药健康人体生物等效性试验

Scientific title：

Randomized, open, two-formulation, two-cycle, crossover, fasting and postprandial administration bioequivalence trial in healthy humans of Cargolizine tablets

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：

田孟丽 

研究负责人：

杨水新 

Applicant：

Tian Mengli 

Study leader：

Yang Suixin 

申请注册联系人电话：

Applicant telephone：

+86 188 6092 8716

研究负责人电话：

Study leader's telephone：

+86 138 1923 3850

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：

2802883249@qq.com

研究负责人电子邮件：

Study leader's E-mail：

phase1@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：

浙江省湖州市吴兴区三环北路1558号

研究负责人通讯地址：

浙江省湖州市吴兴区三环北路1558号

Applicant address：

No.1558, Sanhuan North Road, Wuxing District, Huzhou City, Zhejiang Province

Study leader's address：

No.1558, Sanhuan North Road, Wuxing District, Huzhou City, Zhejiang 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：

湖州市中心医院

Applicant's institution：

Huzhou Central Hospital

研究负责人所在单位：

湖州市中心医院

Affiliation of the Leader：

Huzhou Central Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

伦理第(2023-009-01)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：

湖州市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 Huzhou Central Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2023-04-03 00:00:00

伦理委员会联系人：

蒋凤琴

Contact Name of the ethic committee：

Jiang Fengqin

伦理委员会联系地址：

浙江省湖州市吴兴区三环北路1558号

Contact Address of the ethic committee：

No.1558, Sanhuan North Road, Wuxing District, Huzhou City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 572 270 9719

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：

湖州市中心医院

Primary sponsor：

Huzhou Central Hospital

研究实施负责（组长）单位地址：

浙江省湖州市吴兴区三环北路1558号

Primary sponsor's address：

No.1558, Sanhuan North Road, Wuxing District, Huzhou City, Zhejiang Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江省

市(区县)：

湖州市

Country：

China

Province：

Zhejiang Province

City：

Huzhou City

单位(医院)：

湖州市中心医院

具体地址：

浙江省湖州市吴兴区三环北路1558号

Institution
hospital：

Huzhou Central Hospital

Address：

No.1558, Sanhuan North Road, Wuxing District, Huzhou City, Zhejiang Province

经费或物资来源：

浙江华海药业股份有限公司

Source(s) of funding：

Zhejiang Huahai Pharmaceutical Co.

Target disease：

Diabetes

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：

主要目的： 考察空腹及餐后条件下单次口服受试制剂卡格列净片（浙江华海药业股份有限公司生产）与参比制剂卡格列净片（商品名：INVOKANA?，Janssen-Cilag International NV持证）在健康受试者体内的药代动力学特征，评价空腹及餐后条件下口服给药时两种制剂的生物等效性。 次要目的： 考察受试制剂卡格列净片和参比制剂卡格列净片（INVOKANA?）在健康受试者中的安全性。  

Objectives of Study：

Primary objective: To examine the pharmacokinetic characteristics of a single oral dose of the test formulation, Cagliflozin Tablets (manufactured by Zhejiang Huahai Pharmaceutical Co., Ltd.) and the reference formulation, Cagliflozin Tablets (trade name: INVOKANA?, licensed by Janssen-Cilag International NV), in healthy subjects under fasting and postprandial conditions, and to evaluate the bioequivalence of the two bioequivalence of the two formulations when administered orally under fasting and postprandial conditions. Secondary objectives: To examine the safety of the test formulation of Cargolizine Tablets and the reference formulation of Cargolizine Tablets (INVOKANA?) in healthy subjects.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

满足全部入选标准方可入选。 1） 试验前自愿签署知情同意书，对试验内容、过程及可能出现的不良反应充分了解，自愿参加试验者； 2） 年龄在18~65周岁（含临界值）的健康受试者； 3） 男女均有，男性体重≥50.0 kg，女性体重≥45.0 kg，体重指数（BMI）在19.0~26.0 kg/m2范围内（含临界值）[体重指数（BMI）＝体重（kg）/身高2（m2）]； 4） 体格检查、生命体征检查、实验室检查（血常规、血生化、凝血功能、尿常规、血妊娠（仅限于育龄女性受试者）、输血四项）、心电图检查结果，经研究者判定正常或异常无临床意义； 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

Meet all the inclusion criteria to be selected. 1) Those who voluntarily signed the informed consent form before the trial, fully understood the content, procedure and possible adverse effects of the trial, and voluntarily participated in the trial; 2) Healthy subjects aged 18 to 65 years (including the threshold); 3) Both sexes, male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, body mass index (BMI) in the range of 19.0~26.0 kg/m2 (including the critical value) [body mass index (BMI) = weight (kg)/height2 (m2)]; 4) Physical examination, vital signs examination, laboratory tests (routine blood, blood biochemistry, coagulation, routine urine, blood pregnancy (only for female subjects of childbearing age), transfusion IV), and electrocardiogram results that are judged by the investigator to be normal or abnormal without clinical significance; 5) Those who are able to communicate well with the investigator and understand and comply with the requirements of this study.

排除标准：

符合下述任一排除标准者，不得作为受试者入选。 1） 有内分泌系统、消化系统、泌尿系统、循环系统、血液系统、呼吸系统、运动系统、生殖系统、精神神经系统等疾病史及有可能会影响药物吸收、分布、代谢、排泄的病史，且经研究者判断不适合参加本临床试验者； 2） 过敏体质者（如对两种或以上食物、药物过敏者），或已知对卡格列净片任何成分过敏者； 3） 筛选前6个月内或筛选期间接受过手术，或接受过影响药物吸收、分布、代谢、排泄的手术，或计划在研究期间进行手术者； 4） 筛选前3个月内或筛选期间每日吸烟量≥5支或首次给药前48 h开始至试验结束期间不能停止使用任何烟草类产品者； 5） 筛选前6个月内或筛选期间经常饮酒，即每周饮酒超过14单位酒精（1单位=啤酒（酒精量为5%）357 mL，或高度白酒（酒精量为40%）43 mL，或葡萄酒（酒精量为12%）147 mL），或自首次给药前48小时至试验结束不能停止食用任何含酒精制品者； 6） 入住时酒精呼气检查结果大于0.0 mg/100 mL； 7） 在筛选前3个月内或筛选期献血或大量失血≥400 mL（不包括女性月经血量），或计划在试验期间献血或血液成分者； 8） 有晕针、晕血史，不能耐受静脉穿刺者，或采血困难者，或静脉条件评估不合格者； 9） 筛选前3个月内或筛选期间参加过其他临床试验且使用过其他临床试验用药品或试验器械者，或计划在本研究期间参加其他临床试验者，或非本人来参加临床试验者； 10） 筛选前6个月内有药物滥用史者； 11） 筛选前14天内或筛选期间使用了任何药物者（包括处方药、非处方药、中草药、保健品等），或筛选前28天内或筛选期间使用了任何与卡格列净有相互作用的药物者； 12） 对饮食有特殊要求，不能遵守统一饮食或有吞咽困难者，或最近在饮食或运动习惯上有重大变化者； 13） 乳糖不耐受者（曾发生过喝牛奶腹泻者）； 14） 妊娠或哺乳期妇女，或血妊娠异常且经研究者判定具有临床意义者；受试者（或其伴侣）在筛选日至末次给药后3个月内有生育计划，试验期间不愿采取一种或一种以上的非药物避孕措施（如完全禁欲、避孕套、结扎等）者，或受试者在筛选日至末次给药后3个月内有捐精、捐卵计划者； 15） 筛选前3个月内或筛选期间饮用过量（一天8杯以上，1杯=250mL）茶、咖啡或含咖啡因的饮料者； 16） 筛选前14天内或筛选期间摄入大量富含葡萄柚（即西柚）、柚子、杨桃、芒果、火龙果的饮料或食物者，或首次给药前48小时至试验结束不能停止食用巧克力、任何含咖啡因或有可能影响试验结果的食物或饮料（例如含葡萄柚（即西柚）、柚子、杨桃、芒果、火龙果的饮料或食物）者； 17） 药物滥用筛查呈阳性者，或筛选前3个月内使用过毒品者； 18） 筛选前1个月内接受过疫苗接种者，或试验期间计划接种疫苗者； 19） 空腹血糖大于6.1 mmol/L或低于3.9 mmol/L者； 20） 研究者认为不宜参加本试验者。

Exclusion criteria：

Subjects who meet any of the following exclusion criteria shall not be enrolled as subjects. 1) Persons with a history of endocrine, digestive, urinary, circulatory, hematologic, respiratory, motor, reproductive, or psychoneurological disorders and a history of medical conditions that may affect the absorption, distribution, metabolism, or excretion of the drug and who, in the judgment of the investigator, are not suitable for participation in this clinical trial; 2) Allergic individuals (e.g., those with allergy to two or more foods or drugs) or those with known allergy to any component of Cargolizine Tablets; 3) Those who have undergone surgery within 6 months prior to screening or during screening, or have undergone surgery that affects the absorption, distribution, metabolism, or excretion of the drug, or who are scheduled to undergo surgery during the study period; 4) Those who smoked ≥ 5 cigarettes per day within 3 months prior to screening or during screening or who were unable to stop using any tobacco-based products from 48 h prior to the first dose until the end of the trial 5) Regular alcohol drinkers within 6 months prior to or during the screening period, i.e., those who consume more than 14 units of alcohol per week (1 unit = 357 mL of beer (5% alcohol by volume), or 43 mL of high alcohol (40% alcohol by volume), or 147 mL of wine (12% alcohol by volume)), or those who cannot stop consuming any alcohol-containing products from 48 hours prior to the first dose until the end of the trial; 6) An alcohol breath test result greater than 0.0 mg/100 mL at the time of admission; 7) who donated blood or lost a significant amount of blood ≥ 400 mL (excluding female menstrual blood volume) within 3 months prior to screening or during the screening period, or who plan to donate blood or blood components during the trial 8) Those with a history of needle sickness or blood sickness, those who cannot tolerate venipuncture, or those who have difficulty collecting blood, or those who fail venous condition assessment; 9) Those who have participated in other clinical trials and used other drugs or test devices for clinical trials within 3 months prior to or during the screening period, or those who plan to participate in other clinical trials during this study, or those who do not come to participate in clinical trials themselves; 10) Those who have a history of substance abuse within 6 months prior to screening 11) Those who have used any medications (including prescription drugs, over-the-counter drugs, herbal medicines, health supplements, etc.) within 14 days prior to screening or during screening, or those who have used any drugs that interact with Cagliflozin within 28 days prior to screening or during screening; 12) Those with special dietary requirements, who are unable to comply with a uniform diet or have difficulty swallowing, or who have recently undergone significant changes in dietary or exercise habits 13) Those who are lactose intolerant (those who have experienced diarrhea from drinking milk) 14) Pregnant or lactating women, or those with abnormal blood pregnancy that is judged by the investigator to be clinically significant; subjects (or their partners) who have plans to have children within 3 months of the screening date to the last dose and who do not wish to use one or more non-pharmacological contraceptive measures (e.g., total abstinence, condoms, ligation, etc.) during the trial, or subjects who have plans to donate sperm or eggs within 3 months of the screening date to the last dose 15) Those who have consumed excessive (more than 8 cups a day, 1 cup = 250mL) tea, coffee or caffeinated beverages within 3 months prior to screening or during screening (16) Those who consumed large amounts of beverages or foods rich in grapefruit (i.e., grapefruit), pomelo, peach, mango, or dragon fruit within 14 days prior to or during screening, or those who were unable to stop consuming chocolate, any food or beverage containing caffeine or having the potential to affect the results of the test (e.g., beverages or foods containing grapefruit (i.e., grapefruit), pomelo, peach, mango, or dragon fruit) 48 hours prior to the first dose until the end of the test ) 17) Those who screen positive for substance abuse or have used drugs within 3 months prior to screening 18) those who have received vaccinations within 1 month prior to screening, or those who are scheduled to receive vaccinations during the trial 19) Those with fasting blood glucose greater than 6.1 mmol/L or less than 3.9 mmol/L 20) Those who, in the opinion of the investigator, are unfit to participate in this trial.

研究实施时间：

Study execute time：

从 From 2023-05-20 00:00:00至 To 2023-06-23 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-05-20 00:00:00 至 To 2023-05-29 00:00:00  

干预措施：

Interventions：

组别：

空腹R-T组

样本量：

14

Group：

Fasting R-T group

Sample size：

干预措施：

受试者空腹状况下在第一周期服用R药一片，第二周期服用T药一片

干预措施代码：

Intervention：

Subjects take one tablet of R medication in the first cycle and one tablet of T medication in the second cycle on an empty stomach

Intervention code：

组别：

空腹T-R组

样本量：

14

Group：

Fasting T-R group

Sample size：

干预措施：

受试者空腹状况下在第一周期服用T药一片，第二周期服用R药一片

干预措施代码：

Intervention：

Subjects take one tablet of T medication in the first cycle and one tablet of R medication in the second cycle on an empty stomach

Intervention code：

组别：

餐后T-R组

样本量：

14

Group：

Postprandial T-R group

Sample size：

干预措施：

受试者在服用高脂餐后第一周期服用T药一片，第二周期服用R药一片

干预措施代码：

Intervention：

After taking a high-fat meal, the subjects took one tablet of T-medication in the first cycle and one tablet of R-medication in the second cycle

Intervention code：

组别：

餐后R-T组

样本量：

14

Group：

Postprandial R-T group

Sample size：

干预措施：

受试者在服用高脂餐后第一周期服用R药一片，第二周期服用T药一片

干预措施代码：

Intervention：

After taking a high-fat meal, the subjects took one tablet of R-medication in the first cycle and one tablet of T-medication in the second cycle

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

 湖州 

Country：

China 

Province：

Zhejiang 

City：

Huzhou 

单位(医院)：

湖州市中心医院 

单位级别：

三级甲等 

Institution
hospital：

Huzhou Central Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血药浓度

指标类型：

主要指标

Outcome：

plasma 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：

峰浓度

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：

从0时刻到可检测最低血药浓度的时间内曲线下面积

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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 65 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）：

空腹和餐后试验分别随机，随机表由统计单位应用SAS（9.4或以上版本）按区组随机产生。

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

The fasting and postprandial trials were randomized separately, and the randomization table was randomly generated by the statistical unit using SAS (version 9.4 or above)

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：

开放

Blinding：

open

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

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）：

NA

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：

NA

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：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-05-19 09:34:10