[Translation] A single-center, open, balanced, randomized, single-dose, two-sequence, two-period, double-crossover bioequivalence study of terazosin hydrochloride tablets in healthy subjects under fasting conditions
主要目的:比较空腹给药条件下,中山可可康制药有限公司提供的盐酸特拉唑嗪片(2mg/片)与上海雅培制药有限公司生产的盐酸特拉唑嗪片(2mg/片,商品名:高特灵®)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:评价空腹给药条件下,中山可可康制药有限公司提供的盐酸特拉唑嗪片(2mg/片)的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of terazosin hydrochloride tablets (2 mg/tablet) provided by Zhongshan Kekekang Pharmaceutical Co., Ltd. and terazosin hydrochloride tablets (2 mg/tablet, trade name: Gaotling®) produced by Shanghai Abbott Pharmaceutical Co., Ltd. in healthy adults under fasting conditions, and to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of terazosin hydrochloride tablets (2 mg/tablet) provided by Zhongshan Kekekang Pharmaceutical Co., Ltd. under fasting conditions.