[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence, double-crossover fasting/fed bioequivalence study of empagliflozin tablets in healthy subjects
以药代动力学参数作为主要终点评价指标,分别比较在空腹/餐后状态下口服受试制剂恩格列净片(持证商:德州博诚制药有限公司)与参比制剂恩格列净片(持证商:Boehringer Ingelheim InternationalGmbH,商品名:欧唐静®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。观察受试制剂恩格列净片和参比制剂恩格列净片在健康受试者中的安全性。
[Translation] The pharmacokinetic parameters were used as the primary endpoints to compare the pharmacokinetic behavior of the test preparation, empagliflozin tablets (licensed by: Dezhou Bocheng Pharmaceutical Co., Ltd.) and the reference preparation, empagliflozin tablets (licensed by: Boehringer Ingelheim International GmbH, trade name: Otangjing®) in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations. The safety of the test preparation, empagliflozin tablets, and the reference preparation, empagliflozin tablets, in healthy subjects was observed.