[Translation] An open-label, randomized, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of dapagliflozin tablets in healthy participants under fasting and postprandial conditions.
研究空腹与餐后状态下单次口服受试制剂(达格列净片,规格10mg(以C21H25ClO6计),华益药业科技(安徽)有限公司持证)与参比制剂(达格列净片,规格10mg(以C21H25ClO6计),商品名安达唐/FORXIGA,AstraZeneca AB持证)在健康参与者体内的药代动力学特征,比较受试制剂与参比制剂的生物等效性,并研究药物在健康参与者体内的安全性。
[Translation] This study investigated the pharmacokinetic characteristics of a single oral dose of the test formulation (dapagliflozin tablets, 10 mg (C21H25ClO6), certified by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.) and the reference formulation (dapagliflozin tablets, 10 mg (C21H25ClO6), trade name FORXIGA, certified by AstraZeneca AB) in healthy participants under fasting and postprandial conditions, compared the bioequivalence of the test and reference formulations, and studied the safety of the drugs in healthy participants.