[Translation] A single-center, randomized, open-label, two-dose, two-period, single-dose, fasting, self-crossover bioequivalence study of dapagliflozin tablets developed by Zhejiang Qizheng Pharmaceutical Co., Ltd. and the original reference preparation in healthy Chinese subjects
以浙江麒正药业有限公司研制的达格列净片(规格:10mg)为受试制剂,原研AstraZeneca AB持证的达格列净片(规格:10mg,商品名:安达唐®)为参比制剂,在空腹状态下评价受试制剂和参比制剂在健康受试者中的生物等效性和安全性。
[Translation] Dapagliflozin tablets (specification: 10 mg) developed by Zhejiang Qizheng Pharmaceutical Co., Ltd. were used as the test preparation, and dapagliflozin tablets (specification: 10 mg, trade name: Andatang®) originally developed by AstraZeneca AB were used as the reference preparation. The bioequivalence and safety of the test preparation and the reference preparation were evaluated in healthy subjects under the fasting state.