[Translation] A single-center, open-label, balanced, randomized, single-dose, two-period, double-crossover bioequivalence study of dapoxetine 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,江西仁齐制药有限公司提供的盐酸达泊西汀 片(30mg/片)与Berlin-Chemie AG持证的盐酸达泊西汀片(30mg/片,商品名: Priligy®)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,江西仁齐制药有限公司提供的盐酸达泊西汀片(30mg/片)的安全性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of dapoxetine hydrochloride tablets (30 mg/tablet) provided by Jiangxi Renqi Pharmaceutical Co., Ltd. and dapoxetine hydrochloride tablets (30 mg/tablet, trade name: Priligy®) certified by Berlin-Chemie AG in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of dapoxetine hydrochloride tablets (30 mg/tablet) provided by Jiangxi Renqi Pharmaceutical Co., Ltd. under fasting and postprandial administration conditions.