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：	ChiCTR2500112749
最近更新日期： Date of Last Refreshed on：	2025-11-19 09:47:47
注册时间： Date of Registration：	2025-11-19 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	利格列汀片生物等效性试验
Public title：	Bioequivalence test of linagliptin tablets
注册题目简写：
English Acronym：
研究课题的正式科学名称：	利格列汀片在健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验
Scientific title：	Single center, open label, randomized, single dose, two cycles, two crossover fasting and postprandial bioequivalence trial of linagliptin tablets in healthy subjects
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 18922238175	研究负责人电话： Study leader's telephone：	+86 20 34859951
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：	中国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：	中国广东省广州市番禺区桥南街福愉东路8号
Applicant address：	No. 8, Fuyu East Road, Qian'an Street, Panyu District, Guangzhou, Guangdong, China	Study leader's address：	No. 8, Fuyu East Road, Qian'an Street, Panyu District, Guangzhou, Guangdong, 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：	广州医科大学附属番禺中心医院
Applicant's institution：	Panyu Central Hospital Affiliated to Guangzhou Medical University
研究负责人所在单位：	广州医科大学附属番禺中心医院
Affiliation of the Leader：	The Affiliated Panyu Central Hospital, Guangzhou Medical University

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：	2024-004（YW）-01	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 for Drug Clinical Trials of Guangzhou Panyou District Central Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-02-28 00:00:00
伦理委员会联系人：	冯富肩
Contact Name of the ethic committee：	Feng Fujian
伦理委员会联系地址：	中国广东省广州市番禺区桥南街福愉东路8号
Contact Address of the ethic committee：	No. 8, Fuyu East Road, Qian'an Street, Panyu District, Guangzhou, Guangdong, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 20 34859967	伦理委员会联系人邮箱： Contact email of the ethic committee：	531177697@qq.com

研究实施负责（组长）单位：

广州医科大学附属番禺中心医院

Primary sponsor：

The Affiliated Panyu Central Hospital, Guangzhou Medical University

研究实施负责（组长）单位地址：

中国广东省广州市番禺区桥南街福愉东路8号

Primary sponsor's address：

No. 8, Fuyu East Road, Qian'an Street, Panyu District, Guangzhou, Guangdong, 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)：	广东	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	广州医科大学附属番禺中心医院	具体地址：	中国广东省广州市番禺区桥南街福愉东路8号
Institution hospital：	The Affiliated Panyu Central Hospital, Guangzhou Medical University	Address：	No. 8, Fuyu East Road, Qian'an Street, Panyu District, Guangzhou, Guangdong, China

经费或物资来源：

北京舒曼德医药科技开发有限公司

Source(s) of funding：

Beijing Shumand Medical Technology Development Co., LTD

研究疾病：

2型糖尿病

Target disease：

Type 2 diabetes

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：

健康受试者空腹或餐后状态下，单次口服山西德元堂药业有限公司提供的受试制剂利格列汀片（5mg）与Boehringer Ingelheim International GmbH持证的参比制剂利格列汀片（5mg，商品名：欧唐宁®/Trajenta®），分别考察空腹或餐后状态下受试制剂与参比制剂在健康受试者体内的药代动力学参数，评价两制剂的生物等效性。

Objectives of Study：

Healthy subjects may take a single oral dose of the test formulation linagliptin tablets (5 mg) provided by Shanxi Deyuantang Pharmaceutical Co., Ltd. or the reference formulation licensed linagliptin tablets (5 mg, trade name: O'Donnell®/Trajenta®) from Boehringer Ingelheim International GmbH in fasting or postprandial state to investigate the pharmacokinetic parameters of the subject formulation and the reference formulation in fasting or postprandial state, respectively. The pharmacokinetic parameters of the subject formulation and the reference formulation were investigated in healthy subjects in fasted or postprandial state, respectively, to evaluate the bioequivalence of the two 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) Fully understand the purpose, nature, methods of the trial, as well as the possible adverse reactions, and voluntarily participate as a subject. Sign the informed consent form by oneself before any research procedure begins.
2) Healthy male or female subjects aged 18 years or older.
3) Male weight >= 50.0 kg, female weight >= 45.0 kg; body mass index (BMI) within the range of 19.0 - 26.0 kg/m2 (including the critical value).
4) Physical examination, physical assessment, clinical laboratory tests (blood routine test, urine dry chemical + urine sediment quantitative test, blood biochemical test, infection eight-item test, coagulation four-item test, blood pregnancy test (only for females)), alcohol breath test, drug abuse screening, 12-lead electrocardiogram test results judged by the research doctor as normal or with no clinical significance.
5) Within 3 months after signing the informed consent form, there is no pregnancy plan and voluntarily take effective contraceptive measures (Appendix 2), and no sperm donation or egg donation plans.
6) Able to communicate well with the researcher and be able to understand and comply with all requirements of this study.

排除标准：

1) 过敏体质，如已知对两种或以上物质有过敏史者，或已知利格列汀片或者其辅料有过敏史，有速发型过敏反应、剥脱性皮炎、荨麻疹、血管性水肿等超敏反应病史； 2) 有吞咽困难或有任何影响药物吸收或增加用药安全风险的胃肠道疾病史（如慢性腹泻、巴雷特食管、其他食管疾病、胃炎、十二指肠炎、消化性溃疡等）者； 3) 存在任何血液循环系统、消化系统、泌尿系统、呼吸系统、神经系统、免疫系统、内分泌系统、精神异常或代谢异常等任何慢性或严重疾病史，或经历过经研究者判断可能会影响药物吸收、分布、代谢、排泄，干扰试验结果的任何其他疾病； 4) 有胰腺炎病史者或者有低血糖病史、心力衰竭病史以及肾功能损伤病史者； 5) 试验前6个月内经历过经研究者判断会影响药物吸收、分布、代谢、排泄的手术，或计划在研究期间至研究结束后1周内进行手术者； 6) 血管穿刺条件差，或不能耐受静脉穿刺者，或有晕针晕血史者； 7) 筛选前6 个月内有药物滥用史者，或筛选前3 个月内使用过毒品者，包括非医疗目的反复、大量地使用各类麻醉药品和精神药物，或尿液成瘾药物吗啡、甲基安非他明（冰毒）、氯胺酮、二亚甲基双氧安非他明（摇头丸）、四氢大麻酚酸（大麻）筛查试验任何一项或多项结果为阳性者； 8) 筛选前3 个月内参加过或正在参加其他的药物临床试验者，或使用过本试验相关药物者； 9) 筛选前3 个月内献血包括成分血或大量失血（≥400mL）（女性生理性失血除外），接受输血或使用血制品者；或打算在试验期间或试验结束后3 个月内献血（包括血液成份）者； 10) 女性处在妊娠期、哺乳期，或女性在计划给药前14 天内有未保护性行为或血妊娠检查结果阳性者； 11) 女性试验前30 天内使用口服避孕药者； 12) 女性试验前6 个月内使用长效雌激素或孕激素注射剂（含孕激素型宫内节育器）或埋植片者； 13) 筛选前14天内使用过任何处方药、非处方药、中草药、保健品和维生素者； 14) 试验前4周内接受过疫苗接种者，或计划在试验期间接种疫苗者； 15) 筛选前3个月内每日吸烟量大于5支，或首次给药前48h内和整个试验期间不能停止使用任何烟草类产品者，包括任何包含尼古丁的戒烟产品； 16) 筛选前3个月内平均每周饮酒超过14单位酒精（1单位=360mL啤酒或45mL酒精量为40%的白酒或150mL葡萄酒），或首次给药前48h内和试验期间不能禁酒者，或酒精呼气试验结果大于0.0mg/100mL者； 17) 在筛选前3个月内每天饮用过量浓茶、咖啡和/或含咖啡因的饮料（8杯以上，1杯=250mL）； 18) 在首次给药前48h内摄取过浓茶、巧克力、咖啡或含咖啡因、含酒精、含黄嘌呤（如凤尾鱼、沙丁鱼、牛肝、牛肾等）、葡萄柚（汁）或西柚（汁）的食物或饮料者； 19) 对饮食有特殊要求，不能接受统一饮食（如不能耐受牛奶、鸡蛋、黄油、培根等食物）者，乳糖不耐受者、乳糖酶缺乏或葡萄糖-半乳糖吸收不良病史者； 20) 在研究前筛选阶段或研究用药前发生急性疾病者； 21) 其它研究者判定不适宜参加本项临床研究的受试者。

Exclusion criteria：

1) Allergy, such as a known history of allergy to two or more substances, or a known history of allergy to ligagliptin tablets or its excipients, a history of hypersensitivity reactions such as rapid allergic reactions, exfoliative dermatitis, urticaria, angioedema, etc. 2) Have difficulty swallowing or have any history of gastrointestinal diseases that affect drug absorption or increase drug safety risk (such as chronic diarrhea, Barrett's esophagus, other esophageal diseases, gastritis, duodenitis, peptic ulcer, etc.); 3) Have any history of chronic or serious diseases of the blood circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental or metabolic disorders, or have experienced any other diseases that the investigator judges may affect drug absorption, distribution, metabolism, excretion, or interfere with the test results; 4) Patients with a history of pancreatitis or a history of hypoglycemia, heart failure and renal function injury; 5) Those who had undergone surgery within 6 months prior to the trial that the investigator determined would affect drug absorption, distribution, metabolism, or excretion, or planned to undergo surgery between the study period and 1 week after the study; 6) Poor vascular puncture conditions, or can not tolerate venous puncture, or have a history of fainting needle and fainting blood; 7) Those who have a history of drug abuse in the six months prior to screening, or who have used drugs in the three months prior to screening, including repeated and heavy use of narcotic drugs and psychotropic substances for non-medical purposes, Or urine addictive drugs morphine, methamphetamine (methamphetamine), ketamine, dimethylene dioxyamphetamine (ecstasy), tetrahydrocannabinol (cannabis) screening test any one or more positive results; 8) Participants who have participated in or are participating in other drug clinical trials within 3 months before screening, or have used drugs related to this trial; 9) Blood donation including blood components or massive blood loss (>=400mL) (excluding physiological blood loss in women), transfusion or use of blood products within 3 months before screening; Or those who plan to donate blood (including blood components) during or within 3 months after the trial; 10) The woman is pregnant, breastfeeding, or the woman has unprotected sex or a positive blood pregnancy test within 14 days before the planned drug administration; 11) Women who used oral contraceptives within 30 days before the trial; 12) Women who use long-acting estrogen or progesterone injections (including progesterone IUD) or implants within 6 months before the trial; 13) People who have used any prescription drugs, over-the-counter drugs, Chinese herbs, health products and vitamins within 14 days before screening; 14) Those who received vaccination within 4 weeks prior to the trial, or who plan to receive vaccination during the trial; 15) Smokers who smoked more than 5 cigarettes per day in the 3 months prior to screening, or who could not stop using any tobacco products, including any smoking cessation products containing nicotine, within 48 hours prior to the first dose and throughout the trial period; 16) Those who consumed an average of more than 14 units of alcohol per week in the 3 months prior to screening (1 unit =360mL beer or 45mL liquor with 40% alcohol or 150mL wine), or who could not abstinence within 48h prior to first administration and during the trial period, or whose alcohol breath test results were greater than 0.0mg/100mL; 17) Excessive consumption of strong tea, coffee and/or caffeinated beverages per day (more than 8 cups, 1 cup =250mL) in the 3 months prior to screening; 18) Ingested strong tea, chocolate, coffee or food or drink containing caffeine, alcohol, xanthine (such as anchovies, sardines, beef liver, kidney, etc.), grapefruit (juice) or grapefruit (juice) within 48 hours before the first dose; 19) People with special dietary requirements who cannot accept a unified diet (such as intolerance to milk, eggs, butter, bacon and other foods), lactose intolerance, lactase deficiency or a history of glucose-galactose malabsorption; 20) Acute disease occurred during the pre-study screening stage or before the study medication; 21) Subjects determined by other investigators to be unsuitable for participation in this clinical study.

研究实施时间：

Study execute time：

从 From 2024-07-17 00:00:00至 To 2025-01-10 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-07-18 00:00:00 至 To 2025-01-10 00:00:00

干预措施：

Interventions：

组别：	试验组（空腹）	样本量：	30
Group：	Experimental group (fasting)	Sample size：	30
干预措施：	服用试验药物	干预措施代码：
Intervention：	Taking investigational drugs	Intervention code：

组别：	对照组（空腹）	样本量：	30
Group：	Control group (fasting)	Sample size：	30
干预措施：	服用参比药物	干预措施代码：
Intervention：	Taking reference medication	Intervention code：

组别：	试验组（餐后）	样本量：	18
Group：	Experimental group (after meals)	Sample size：	18
干预措施：	服用试验药物	干预措施代码：
Intervention：	Taking investigational drugs	Intervention code：

组别：	对照组（餐后）	样本量：	18
Group：	Control group (after meals)	Sample size：	18
干预措施：	服用参比药物	干预措施代码：
Intervention：	Taking reference medication	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)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	广州医科大学附属番禺中心医院	单位级别：	三级甲等
Institution hospital：	The Affiliated Panyu Central Hospital, Guangzhou Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	从0时到72小时的药物浓度-时间曲线下面积	指标类型：	主要指标
Outcome：	AUC0-72h	Type：	Primary indicator
测量时间点：	2周期血样采集后	测量方法：	采用LC-MS/MS法测定
Measure time point of outcome：	After 2 cycles of blood sample collection	Measure method：	Determination using LC-MS/MS 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：	2周期血样采集后	测量方法：	采用LC-MS/MS法测定
Measure time point of outcome：	After 2 cycles of blood sample collection	Measure method：	Determination using LC-MS/MS method

指标中文名：	达峰浓度的时间	指标类型：	次要指标
Outcome：	Tmax	Type：	Secondary indicator
测量时间点：	根据血药浓度-时间实测数据直接获得	测量方法：	采用LC-MS/MS法测定
Measure time point of outcome：	Obtained directly from the actual measured data of blood drug concentration-time.	Measure method：	Determination using LC-MS/MS method

指标中文名：	末端相的血药浓度消除速率常数	指标类型：	次要指标
Outcome：	λz	Type：	Secondary indicator
测量时间点：	2周期血样采集后	测量方法：	采用LC-MS/MS法测定
Measure time point of outcome：	After 2 cycles of blood sample collection	Measure method：	Determination using LC-MS/MS method

指标中文名：	消除终末端半衰期	指标类型：	次要指标
Outcome：	t1/2	Type：	Secondary indicator
测量时间点：	按照ln2/λz计算	测量方法：	采用LC-MS/MS法测定
Measure time point of outcome：	Calculate according to ln2/λz	Measure method：	Determination using LC-MS/MS 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		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）：

由统计单位应用SAS（9.4或更高版本）用区组随机法生成随机分配表

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

Generate a random allocation table using block randomization method using SAS (version 9.4 or higher) applied by statistical units.

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	是Yes
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）：	国家生物信息中心，在试验结束6个月内上传试验数据。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The National Biomedical Information Center is required to upload the test data within six months after the completion of the experiment.
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和病历报告表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	EDC and CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2025-11-19 09:47:38