[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting/fed bioequivalence study of dapagliflozin tablets in healthy subjects
主要目的: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达格列净片(生产厂家:石家庄市华新药业有限责任公司)与参比制剂达格列净片(持证商:AstraZeneca AB,商品名:安达唐®)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。
次要目的:观察受试制剂达格列净片和参比制剂达格列净片在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation indicators, the pharmacokinetic behavior of the test preparation dapagliflozin tablets (manufacturer: Shijiazhuang Huaxin Pharmaceutical Co., Ltd.) and the reference preparation dapagliflozin tablets (licensed manufacturer: AstraZeneca AB, trade name: Andatang®) in healthy subjects after oral administration in the fasting/postprandial state was compared to evaluate the bioequivalence of the two preparations.
Secondary purpose: Observe the safety of the test preparation dapagliflozin tablets and the reference preparation dapagliflozin tablets in healthy subjects.