[Translation] A single-center, randomized, open-label, two-dose, single-dose, two-period, double-crossover fasting/fed bioequivalence study of trihexyphenidyl hydrochloride tablets in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,分别比较在空腹餐后状态下口服受试制剂盐酸苯海索片(规格:2mg,持证商:海鸿恒隆(海南)生物科技有限公司)与参比制剂盐酸苯海索片(规格:2mg,持证商:WATSON LABORATORIES INC INC,商品名:Trihexyphenidyl Hydrochloride ® )后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:观察受试制剂盐酸苯海索片和参比制剂盐酸苯海索片在健康受试者中的安全性。
[Translation] Main purpose: Using pharmacokinetic parameters as the primary endpoint evaluation index, the pharmacokinetic behavior of the test preparation Trihexyphenidyl Hydrochloride Tablets (Specification: 2mg, licensee: Haihong Henglong (Hainan) Biotechnology Co., Ltd.) and the reference preparation Trihexyphenidyl Hydrochloride Tablets (Specification: 2mg, licensee: WATSON LABORATORIES INC INC, trade name: Trihexyphenidyl Hydrochloride ® ) were compared in healthy subjects after oral administration in the fasting state, and the bioequivalence of the two preparations was evaluated.
Secondary purpose: To observe the safety of the test preparation Trihexyphenidyl Hydrochloride Tablets and the reference preparation Trihexyphenidyl Hydrochloride Tablets in healthy subjects.