[Translation] A single-center, open-label, balanced, randomized, single-dose, two-period, double-crossover bioequivalence study of paroxetine hydrochloride tablets in healthy subjects under fasting and fed conditions
主要目的:
比较空腹及餐后给药条件下,江苏睿实生物科技有限公司提供的盐酸帕罗西汀片(20mg/片)与Apotex Technologies Inc持证的盐酸帕罗西汀片(20mg/片,商品名:Paxil®)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:
评估江苏睿实生物科技有限公司提供的盐酸帕罗西汀片(20mg/片)与Apotex Technologies Inc持证的盐酸帕罗西汀片(20mg/片,商品名:Paxil®)在健康成年人群中的安全性。
[Translation] Primary objective:
To compare the differences in the extent and rate of absorption of paroxetine hydrochloride tablets (20 mg/tablet) provided by Jiangsu Ruishi Biotechnology Co., Ltd. and paroxetine hydrochloride tablets (20 mg/tablet, trade name: Paxil®) certified by Apotex Technologies Inc. in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective:
To evaluate the safety of paroxetine hydrochloride tablets (20 mg/tablet) provided by Jiangsu Ruishi Biotechnology Co., Ltd. and paroxetine hydrochloride tablets (20 mg/tablet, trade name: Paxil®) certified by Apotex Technologies Inc. in healthy adults.