[Translation] A single-center, randomized, open-label, two-formulation, two-period, two-sequence, single-dose, double-crossover bioequivalence study of empagliflozin tablets in Chinese healthy subjects under fasting and fed conditions
1)主要目的:以恩格列净的主要药代动力学参数(AUC和Cmax)为生物等效性评价指标,在中国健康受试者空腹和餐后状态下评估受试制剂(山东鲁宁药业有限公司生产的恩格列净片,规格:25mg)和参比制剂(Boehringer Ingelheim International GmbH持证的恩格列净片,规格:25mg;商品名:Jardiance®)的生物等效性。
2)次要目的:观察空腹和餐后状态下受试制剂和参比制剂的安全性。
[Translation] 1) Primary objective: To evaluate the bioequivalence of the test formulation (Empagliflozin tablets produced by Shandong Luning Pharmaceutical Co., Ltd., specification: 25 mg) and the reference formulation (Empagliflozin tablets certified by Boehringer Ingelheim International GmbH, specification: 25 mg; trade name: Jardiance®) in Chinese healthy subjects under fasting and fed conditions, using the main pharmacokinetic parameters (AUC and Cmax) of Empagliflozin as bioequivalence evaluation indicators.
2) Secondary objective: To observe the safety of the test formulation and the reference formulation under fasting and fed conditions.