[Translation] A study of Changchun Haiyue Pharmaceutical Co., Ltd.’s sitagliptin metformin extended-release tablets and Merck Sharp and Dohme Corp.’s sitagliptin metformin extended-release tablets (trade name: Janumet Xr®) was conducted in Chinese healthy subjects Single-center, randomized, open-label, two-formulation, fasting and postprandial, single-dose, two-cycle, double-crossover design bioequivalence study
以长春海悦药业股份有限公司的西格列汀二甲双胍缓释片(100mg/1000mg)为受试制剂,Merck Sharp and Dohme Corp.上市的西格列汀二甲双胍缓释片(Janumet Xr®,规格100mg/1000mg)为参比制剂,考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性,同时评价两制剂在健康受试者中的安全性
[Translation] Taking Changchun Haiyue Pharmaceutical Co., Ltd.’s sitagliptin metformin extended-release tablets (100mg/1000mg) as the test preparation, Merck Sharp and Dohme Corp.’s sitagliptin metformin extended-release tablets (Janumet Xr®, specification 100mg/1000mg) as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations in single administration under fasting and postprandial conditions were examined to evaluate whether the two preparations are bioequivalent and at the same time to evaluate the effectiveness of the two preparations. Safety in healthy subjects