[Translation] A single-center, randomized, open-label, two-dose, two-period, two-sequence, single-dose, double-crossover bioequivalence study of safinamide mesylate tablets in Chinese healthy volunteers under fasting and fed conditions
主要目的:以沙芬酰胺的主要药代动力学参数(AUC和Cmax)为生物等效性的评价指标,在中国健康受试者空腹和餐后状态下评估受试制剂(成都明德至远医药科技有限公司委托四川宏明博思药业有限公司生产的甲磺酸沙芬酰胺片,规格100mg)和参比制剂(Zambon S.p.A.持证的甲磺酸沙芬酰胺片,规格100mg,商品名:Xadago®)的生物等效性。
[Translation] Main objective: To evaluate the bioequivalence of the test preparation (100 mg safinamide mesylate tablets produced by Sichuan Hongming Bosi Pharmaceutical Co., Ltd. commissioned by Chengdu Mingde Zhiyuan Pharmaceutical Technology Co., Ltd.) and the reference preparation (100 mg safinamide mesylate tablets certified by Zambon S.p.A., trade name: Xadago®) in Chinese healthy subjects under fasting and fed conditions, using the main pharmacokinetic parameters (AUC and Cmax) of safinamide as evaluation indicators of bioequivalence.