二甲双胍恩格列净片随机、开放、两制剂、两周期、交叉、健康人体空腹和餐后生物等效性试验
[Translation] A randomized, open-label, two-dose, two-period, crossover bioequivalence study of metformin and empagliflozin tablets in healthy volunteers with fasting and fed diet
主要目的:
研究健康人体在空腹和餐后状态下,单次口服北京康立生医药技术开发有限公司的二甲双胍恩格列净片1片(受试制剂,规格:每片含盐酸二甲双胍500mg与恩格列净5mg)和Boehringer Ingelheim Pty Ltd生产的原研二甲双胍恩格列净片(Ⅰ) 1片(参比制剂,Metformin Hydrochloride and Empagliflozin Tablets(Ⅰ)/Synjardy®/欧双静®,规格:每片含盐酸二甲双胍500mg与恩格列净5mg)的相对生物利用度,评价受试制剂和参比制剂的生物等效性。
次要目的:
通过不良事件发生率、实验室检验结果、生命体征和体格检查等的变化情况观察受试制剂和参比制剂在中国健康受试者中的安全性和耐受性。
[Translation] Main objective:
To study the relative bioavailability of a single oral dose of one metformin empagliflozin tablet (test preparation, specification: each tablet contains 500 mg of metformin hydrochloride and 5 mg of empagliflozin) produced by Beijing Kanglisheng Pharmaceutical Technology Development Co., Ltd. and one original metformin empagliflozin tablet (Ⅰ) produced by Boehringer Ingelheim Pty Ltd (reference preparation, Metformin Hydrochloride and Empagliflozin Tablets (Ⅰ)/Synjardy®/Oushuangjing®, specification: each tablet contains 500 mg of metformin hydrochloride and 5 mg of empagliflozin) in healthy subjects in fasting and postprandial states, and to evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary objective:
To observe the safety and tolerability of the test preparation and the reference preparation in healthy Chinese subjects through changes in adverse event incidence, laboratory test results, vital signs and physical examinations.
100 Clinical Results associated with Beijing Kanglisheng Pharmaceutical Technology Development Co., Ltd.
0 Patents (Medical) associated with Beijing Kanglisheng Pharmaceutical Technology Development Co., Ltd.
100 Deals associated with Beijing Kanglisheng Pharmaceutical Technology Development Co., Ltd.
100 Translational Medicine associated with Beijing Kanglisheng Pharmaceutical Technology Development Co., Ltd.