[Translation] A randomized, open-label, single-dose, two-cycle, two-crossover bioequivalence study of glimepiride and metformin tablets in healthy subjects
主要目的:以法国赛诺菲-万安特公司生产Amaryl®M为参比制剂,对比华中药业生产的格列美脲二甲双胍片(受试制剂),考察健康志愿者单次口服格列美脲二甲双胍片在人体的血药浓度及主要药代动力学参数,并评价其生物等效性。次要目的:观察格列美脲二甲双胍片(受试制剂)和格列美脲二甲双胍片(参比制剂)在健康受试者中的安全性。
[Translation] Main purpose: Take Amaryl®M produced by French Sanofi-Vanante as the reference preparation, and compare the glimepiride and metformin tablets (test preparation) produced by Huazhong Pharmaceutical Co. The plasma concentration and main pharmacokinetic parameters of ureametformin tablets in human body, and their bioequivalence was evaluated. Secondary objective: To observe the safety of glimepiride metformin tablets (test preparation) and glimepiride metformin tablets (reference preparation) in healthy subjects.