[Translation] A single-center, open-label, balanced, randomized, single-dose, two-period, double-crossover bioequivalence study of trihexyphenidyl hydrochloride tablets in healthy subjects under fasting and fed conditions
主要目的:空腹及餐后给药条件下,比较湖南中南制药有限责任公司提供的盐酸苯海索片(规格:2 mg/片)与Watson Pharma Private Limited生产的盐酸苯海索片(规格:2 mg/片)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的:评价空腹及餐后给药条件下,受试制剂和参比制剂盐酸苯海索片(2 mg/片)在健康受试者中的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of Benhexyphenidyl Hydrochloride Tablets (Specification: 2 mg/tablet) provided by Hunan Zhongnan Pharmaceutical Co., Ltd. and Benhexyphenidyl Hydrochloride Tablets (Specification: 2 mg/tablet) produced by Watson Pharma Private Limited in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of the test preparation and the reference preparation Benhexyphenidyl Hydrochloride Tablets (2 mg/tablet) in healthy subjects under fasting and postprandial administration conditions.