[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence trial evaluating the investigational formulation dapagliflozin tablets (10 mg) and the reference formulation Andatang®/FORXIGA® (10 mg) in healthy adult participants in fasting condition.
研究空腹状态下单次口服受试制剂达格列净片(规格:10 mg,江苏诚康药业有限公司生产)与参比制剂达格列净片(安达唐®/FORXIGA®,规格:10 mg,AstraZeneca Pharmaceuticals LP 生产)在健康参与者体内的药代动力学,评价空腹状态下口服两种制剂的生物等效性。
[Translation] This study investigated the pharmacokinetics of the test formulation dapagliflozin tablets (10 mg, manufactured by Jiangsu Chengkang Pharmaceutical Co., Ltd.) and the reference formulation dapagliflozin tablets (FORXIGA®, 10 mg, manufactured by AstraZeneca Pharmaceuticals LP) in healthy participants under fasting conditions, and evaluated the bioequivalence of the two formulations under fasting conditions.