[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of dapagliflozin saxagliptin tablets (10 mg/5 mg) in Chinese healthy subjects under fasting and fed conditions
主要目的:以药代动力学参数为终点指标,比较空腹和高脂餐后给药条件下,合肥合源药业有限公司生产的达格列净沙格列汀片与AstraZeneca Pharmaceuticals LP原研的达格列净沙格列汀片(Qtern®)在健康成年人群中吸收程度和速度的差异,对两制剂的生物等效性进行评价。
次要目的:评价健康受试者在空腹和高脂餐后给药条件下口服受试制剂达格列净沙格列汀片和参比制剂达格列净沙格列汀片的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of dapagliflozin saxagliptin tablets produced by Hefei Heyuan Pharmaceutical Co., Ltd. and dapagliflozin saxagliptin tablets (Qtern®) originally developed by AstraZeneca Pharmaceuticals LP in healthy adults under fasting and high-fat meal administration conditions using pharmacokinetic parameters as endpoints, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of oral administration of the test preparation dapagliflozin saxagliptin tablets and the reference preparation dapagliflozin saxagliptin tablets to healthy subjects under fasting and high-fat meal administration conditions.