[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial), two-formulation, two-sequence, two-period, double-crossover bioequivalence study of metformin empagliflozin tablets in healthy Chinese subjects
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂二甲双胍恩格列净片(规格:每片含盐酸二甲双胍850mg与恩格列净12.5mg)和参比制剂二甲双胍恩格列净片(商品名:Synjardy®;规格:每片含盐酸二甲双胍850mg与恩格列净12.5mg;持证商:Boehringer Ingelheim International GmbH)后的药代动力学特征,初步评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂二甲双胍恩格列净片和参比制剂二甲双胍恩格列净片(Synjardy ®)在中国健康受试者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation metformin empagliflozin tablets (specification: each tablet contains 850 mg of metformin hydrochloride and 12.5 mg of empagliflozin) and the reference preparation metformin empagliflozin tablets (trade name: Synjardy®; specification: each tablet contains 850 mg of metformin hydrochloride and 12.5 mg of empagliflozin; licensee: Boehringer Ingelheim International GmbH) after a single oral administration in the fasting/postprandial state in healthy Chinese subjects, and to preliminarily evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary objective: To observe the safety of the test preparation metformin empagliflozin tablets and the reference preparation metformin empagliflozin tablets (Synjardy ®) in healthy Chinese subjects.