[Translation] A single-center, randomized, open-label, fasting and postprandial single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of metformin and empagliflozin tablets (I) in healthy adult Chinese subjects
主要研究目的:
考察单次单剂量口服(空腹/餐后)受试制剂二甲双胍恩格列净片(I)(规格:500mg/5mg,北京圣永制药有限公司委托江苏永安制药有限公司生产)与参比制剂二甲双胍恩格列净片(I)(SYNJARDY?,规格:500mg/5mg,Boehringer Ingelheim Pharmaceuticals Inc 持证),在中国健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性,为该药的申报及临床用药提供参考依据。
次要研究目的:
评价空腹、餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Main study objectives:
To investigate the relative bioavailability of the single-dose oral (fasting/postprandial) test preparation metformin empagliflozin tablets (I) (specification: 500mg/5mg, produced by Jiangsu Yongan Pharmaceutical Co., Ltd. commissioned by Beijing Shengyong Pharmaceutical Co., Ltd.) and the reference preparation metformin empagliflozin tablets (I) (SYNJARDY?, specification: 500mg/5mg, Boehringer Ingelheim Pharmaceuticals Inc. licensed) in healthy Chinese subjects, analyze the pharmacokinetic parameters of the two preparations, evaluate the bioequivalence of the two preparations, and provide a reference for the application and clinical use of the drug.
Secondary study objectives:
To evaluate the safety of the single oral fasting and postprandial test preparations and reference preparations in healthy Chinese adult subjects.