双嘧达莫片在健康受试者中的单剂量、随机、开放、交叉、双周期、空腹喝餐后人体生物等效性试验
[Translation] A single-dose, randomized, open-label, crossover, two-period, fasting and fed human bioequivalence study of dipyridamole tablets in healthy subjects
主要目的:以四川天杏汇医药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] Main purpose: Dipyridamole tablets (specification: 25 mg) of Sichuan Tianxinghui Pharmaceutical Technology Co., Ltd. were used as the test preparation, and dipyridamole tablets (specification: 25 mg) of Medical Parkland Co., Ltd. were used as the reference preparation. According to the relevant provisions of the bioequivalence test, the bioequivalence of the two preparations in healthy humans was investigated.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
100 Clinical Results associated with Sichuan Tianxinghui Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Sichuan Tianxinghui Pharmaceutical Technology Co., Ltd.
100 Deals associated with Sichuan Tianxinghui Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Sichuan Tianxinghui Pharmaceutical Technology Co., Ltd.