[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of dapagliflozin tablets (10 mg) in Chinese healthy subjects under fasting and fed conditions
主要目的:以药代动力学参数为终点指标,比较空腹和高脂餐后给药条件下,合肥合源药业有限公司生产的达格列净片与AstraZeneca AB为持证商的达格列净片(商品名:安达唐®(FORXIGA),规格:10mg)在健康成年人群中吸收程度和速度的差异,对两制剂的生物等效性进行评价。
次要目的:评价健康受试者口服受试制剂达格列净片(规格:10mg)和参比制剂达格列净片(商品名:安达唐®(FORXIGA),规格:10mg)的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of dapagliflozin tablets produced by Hefei Heyuan Pharmaceutical Co., Ltd. and dapagliflozin tablets (trade name: Andatang® (FORXIGA), specification: 10 mg) produced by AstraZeneca AB in healthy adults under fasting and high-fat meal administration conditions using pharmacokinetic parameters as endpoints, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test preparation dapagliflozin tablets (specification: 10 mg) and the reference preparation dapagliflozin tablets (trade name: Andatang® (FORXIGA), specification: 10 mg) taken orally in healthy subjects.