[Translation] A single-center, randomized, open-label, two-dose, fasting and fed, single-dose, two-period, double-crossover bioequivalence study of sitagliptin metformin extended-release tablets from Huazhong Pharmaceutical Co., Ltd. and sitagliptin metformin extended-release tablets (trade name: Janumet Xr®) from Merck Sharp and Dohme Corp. in healthy Chinese subjects
以华中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] Sitagliptin metformin extended-release tablets (100 mg/1000 mg) produced by Huazhong Pharmaceutical Co., Ltd. were used as the test preparation, and sitagliptin metformin extended-release tablets (Janumet Xr®, 100 mg/1000 mg) marketed by Merck Sharp and Dohme Corp. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent, and the safety of the two preparations in healthy subjects was evaluated.