[Translation] A single-center, randomized, open-label, two-preparation, two-cycle, two-sequence, single-dose, double-crossover bioequivalence study of empagliflozin tablets in Chinese healthy subjects under fasting and postprandial 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) Main purpose: Using the main pharmacokinetic parameters (AUC and Cmax) of empagliflozin as bioequivalence evaluation indicators, evaluate the test preparation in Chinese healthy subjects under fasting and postprandial conditions (Shandong Luning Bioequivalence of Empagliflozin Tablets produced by Pharmaceutical Co., Ltd., strength: 25 mg) and the reference preparation (Empagliflozin Tablets, strength: 25 mg, certified by Boehringer Ingelheim International GmbH; trade name: Jardiance®).
2) Secondary purpose: To observe the safety of the test preparation and reference preparation under fasting and postprandial conditions.