[Translation] A single-center, randomized, open-label, two-dose, two-period, two-sequence, single-dose, double-crossover bioequivalence study of empagliflozin tablets in Chinese healthy subjects under fasting and fed conditions
以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(湖南汉森制药股份有限公司生产的恩格列净片,规格25mg)和参比制剂(Boehringer Ingelheim Pharma GmbH & Co. KG生产的恩格列净片,规格25mg,商品名:Jardiance®)的生物等效性。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] The main pharmacokinetic parameters (AUC and Cmax) of empagliflozin were used as bioequivalence evaluation indicators to evaluate the bioequivalence of the test formulation (empagliflozin tablets produced by Hunan Hansen Pharmaceutical Co., Ltd., specification 25 mg) and the reference formulation (empagliflozin tablets produced by Boehringer Ingelheim Pharma GmbH & Co. KG, specification 25 mg, trade name: Jardiance®) in Chinese healthy subjects in the fasting and fed state. The safety of oral administration of the test formulation and the reference formulation in the fasting and fed state was observed.