/ CompletedNot Applicable 双嘧达莫片在健康受试者中的单剂量、随机、开放、交叉、两周期、空腹和餐后人体生物等效性试验
[Translation] A single-dose, randomized, open-label, crossover, two-period, fasting and fed bioequivalence study of dipyridamole tablets in healthy volunteers
主要目的:以成都归合科技有限公司的双嘧达莫片(规格:25mg)为受试制剂,以株式会社medical Parkland的双嘧达莫片(规格:25mg)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary objective: Using dipyridamole tablets (25 mg) from Chengdu Guihe Technology Co., Ltd. as the test formulation and dipyridamole tablets (25 mg) from Medical Parkland Co., Ltd. as the reference formulation, we investigated the bioequivalence of the two formulations in healthy volunteers according to relevant bioequivalence testing regulations.
Secondary objective: To observe the safety of the test and reference formulations in healthy volunteers.
100 Clinical Results associated with Chengdu Guihe Technology Co., Ltd.
0 Patents (Medical) associated with Chengdu Guihe Technology Co., Ltd.
100 Deals associated with Chengdu Guihe Technology Co., Ltd.
100 Translational Medicine associated with Chengdu Guihe Technology Co., Ltd.