[Translation] A single-center, randomized, open-label, single-dose, fasting and postprandial, two-formulation, two-sequence, two-period crossover bioequivalence study of dapagliflozin tablets in healthy adult Chinese subjects
主要目的:
考察空腹/餐后单次口服受试制剂达格列净片(规格:10 mg,海南赛立克药业有限公司生产)与参比制剂达格列净片(商品名:安达唐®,规格:10 mg,AstraZeneca Pharmaceuticals LP生产),在中国成年健康人体的相对生物利用度,分析两种制剂的药代动力学参数,评价两制剂的生物等效性。
次要目的:
评价空腹/餐后单次口服受试制剂和参比制剂在中国成年健康受试者中的安全性。
[Translation] Primary objective:
To investigate the relative bioavailability of the test preparation dapagliflozin tablets (specification: 10 mg, produced by Hainan Celic Pharmaceutical Co., Ltd.) and the reference preparation dapagliflozin tablets (trade name: Andatang®, specification: 10 mg, produced by AstraZeneca Pharmaceuticals LP) in healthy Chinese adults after a single oral administration on an empty stomach/after a meal, analyze the pharmacokinetic parameters of the two preparations, and evaluate the bioequivalence of the two preparations.
Secondary objective:
To evaluate the safety of the test preparation and the reference preparation in healthy Chinese adults after a single oral administration on an empty stomach/after a meal.