[Translation] Single-center, randomized, open-label, single-dose, two-dose, two-period, double-crossover, fasting and fed bioequivalence study of vildagliptin tablets in healthy subjects
1、以河南新天地药业股份有限公司持证的维格列汀片(规格:50mg)为受试制剂T,以Novartis Europharm Ltd.持证的维格列汀片(规格:50mg,商品名:佳维乐/Galvus®)为参比制剂R,比较受试制剂与参比制剂的药代动力学参数,分别评价两制剂在空腹和餐后两种状态下的人体生物等效性。
2、观察受试制剂维格列汀片T和参比制剂维格列汀片R(商品名:佳维乐/Galvus®)在健康受试者中的安全性。
[Translation] 1. Vildagliptin tablets (specification: 50mg) licensed by Henan Xintiandi Pharmaceutical Co., Ltd. were used as the test preparation T, and vildagliptin tablets licensed by Novartis Europharm Ltd. (specification: 50mg, trade name: Galvus/Galvus®) is the reference preparation R, compare the pharmacokinetic parameters of the test preparation and the reference preparation, and evaluate the human bioequivalence of the two preparations under fasting and postprandial conditions.
2. Observe the safety of the test preparation Vildagliptin Tablets T and the reference preparation Vildagliptin Tablets R (trade name: Galvus®) in healthy subjects.