[Translation] This study adopts a single-center, randomized, open, single-dose, two-formulation, two-cycle, two-sequence crossover bioequivalence study in fasting/fed state.
本试验旨在研究健康研究参与者单次空腹和餐后口服安徽省先锋制药有限公司研制、生产的达格列净二甲双胍缓释片(达格列净10 mg(以C21H25ClO6计)和盐酸二甲双胍1000 mg)的药代动力学特征;以AstraZeneca Pharmaceuticals LP生产的达格列净二甲双胍缓释片(Ⅰ)(安达释®,10 mg/1000 mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of dapagliflozin metformin extended-release tablets (dapagliflozin 10 mg (calculated as C21H25ClO6) and metformin hydrochloride 1000 mg) developed and produced by Anhui Pioneer Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration in healthy study participants; dapagliflozin metformin extended-release tablets (Ⅰ) (Anda-Sol®, 10 mg/1000 mg) produced by AstraZeneca Pharmaceuticals LP was used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.