[Translation] A single-center, randomized, open-label, two-dose, two-period, two-sequence, single-dose, double-crossover bioequivalence study of metformin empagliflozin tablets in Chinese healthy volunteers under fasting and fed conditions
主要目的:以二甲双胍恩格列净的主要药代动力学参数(AUC和Cmax)为生物等效性的评价指标,在中国健康受试者空腹和餐后状态下评估受试制剂(重庆华森制药股份有限公司生产的二甲双胍恩格列净片,规格:每片含盐酸二甲双胍1000mg与恩格列净12.5mg)和参比制剂(Boehringer Ingelheim Promeco S.A. de C.V.生产的二甲双胍恩格列净片,规格:每片含盐酸二甲双胍1000mg与恩格列净12.5mg,商品名:Synjardy ®)的生物等效性。
次要目的:观察空腹和餐后状态下口服受试制剂和参比制剂的安全性。
[Translation] Primary objective: To evaluate the bioequivalence of the test formulation (Metformin Empagliflozin Tablets produced by Chongqing Huasen Pharmaceutical Co., Ltd., specifications: each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin) and the reference formulation (Metformin Empagliflozin Tablets produced by Boehringer Ingelheim Promeco S.A. de C.V., specifications: each tablet contains 1000 mg of metformin hydrochloride and 12.5 mg of empagliflozin, trade name: Synjardy ®) in Chinese healthy subjects under fasting and fed conditions, using the main pharmacokinetic parameters (AUC and Cmax) of metformin Empagliflozin as bioequivalence evaluation indicators.
Secondary objective: To observe the safety of oral administration of the test formulation and the reference formulation under fasting and fed conditions.