[Translation] Empagliflozin tablets (25 mg) developed by Kangyuan Warwick Pharmaceutical Co., Ltd. and empagliflozin tablets (Jardiance®, 25 mg) marketed by Boehringer Ingelheim International GmbH were tested in single-center, randomized, open-label, two-preparation, Single-dose, two-cycle, double-crossover, single-dose bioequivalence studies in fasted and postprandial states.
主要目的:以康缘华威医药有限公司研制的恩格列净片(25mg)为受试制剂,Boehringer Ingelheim International GmbH上市的恩格列净片(Jardiance®,25mg)为参比制剂,考察两制剂在空腹和餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。
次要目的:评价中国健康受试者空腹和餐后单次口服恩格列净片受试制剂和参比制剂后的安全性。
[Translation] Main purpose: Empagliflozin tablets (25 mg) developed by Kangyuan Warwick Pharmaceutical Co., Ltd. were used as the test preparation, and empagliflozin tablets (Jardiance®, 25 mg) marketed by Boehringer Ingelheim International GmbH were used as the reference preparation to investigate the two preparations. The pharmacokinetic parameters and relative bioavailability of a single dose in fasting and postprandial states were used to evaluate whether the two preparations are bioequivalent.
Secondary purpose: To evaluate the safety of test and reference preparations of empagliflozin tablets in Chinese healthy subjects after single oral administration on an empty stomach and after a meal.