[Translation] A single-center, single-dose, randomized, open-label, crossover, two-dose, two-period fasting and fed bioequivalence study of safinamide mesylate tablets in healthy subjects
主要目的:以北京颐康兴医药有限公司的甲磺酸沙芬酰胺片(规格:50mg)为受试制剂,以Zambon S.p.A.持证的甲磺酸沙芬酰胺片(Xadago®,规格:50mg)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: Using Beijing Yikangxing Pharmaceutical Co., Ltd.'s Safinamide Mesylate Tablets (Specification: 50 mg) as the test preparation and Zambon S.p.A.'s certified Safinamide Mesylate Tablets (Xadago®, Specification: 50 mg) as the reference preparation, according to the relevant provisions of the bioequivalence test, to investigate the bioequivalence of the two preparations in healthy subjects.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.