[Translation] A single-dose, fasting and fed, randomized, open-label, two-period, two-crossover bioequivalence study of dapagliflozin tablets in healthy subjects
主要研究目的:本研究以海南倍康医药科技有限公司持有的达格列净片(10mg)为受试制剂,以AstraZeneca AB公司持有的原研进口达格列净片(10mg,商品名:安达唐®)为参比制剂,评价受试制剂和参比制剂在空腹和餐后条件下给药时的生物等效性。
次要研究目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main research purpose: This study uses dapagliflozin tablets (10 mg) held by Hainan Beikang Pharmaceutical Technology Co., Ltd. as the test preparation and the original imported dapagliflozin tablets (10 mg, trade name: Andatang®) held by AstraZeneca AB as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation when administered under fasting and postprandial conditions.
Secondary research purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.