[Translation] A single-dose, randomized, open-label, two-dose, two-sequence, two-period, double-crossover, fasting and fed bioequivalence study of dapagliflozin tablets (10 mg) in healthy Chinese subjects
主要研究目的:以AstraZeneca AB持证的达格列净片(商品名:安达唐)为参比制剂,以山东普瑞曼药业有限公司研发的达格列净片为受试制剂,通过单中心、随机、开放、单次给药、两周期、双交叉临床研究来评价两种制剂的人体生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use AstraZeneca AB's licensed dapagliflozin tablets (trade name: Andatang) as the reference preparation and Shandong Pu Ruiman Pharmaceutical Co., Ltd.'s dapagliflozin tablets as the test preparation to evaluate the human bioequivalence of the two preparations through a single-center, randomized, open, single-dose, two-cycle, double-crossover clinical study.
Secondary purpose of the study: to observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.