[Translation] A single-center, open-label, randomized, single-dose, two-dose, four-period, completely repeated crossover bioequivalence study of agomelatine tablets in healthy subjects under fasting and fed conditions
主要目的:比较空腹和餐后给药条件下,沈阳福宁药业有限公司提供的阿戈美拉汀片(25mg)与Les Laboratoires Servier持证的阿戈美拉汀片(25mg,商品名:维度新®)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:评价空腹和餐后给药条件下,沈阳福宁药业有限公司提供的阿戈美拉汀片(25mg)与Les Laboratoires Servier持证的阿戈美拉汀片(25mg,商品名:维度新®)在健康成年人群中的安全性。
[Translation] Main purpose: To compare agomelatine tablets (25mg) provided by Shenyang Funing Pharmaceutical Co., Ltd. and agomelatine tablets (25mg, brand name: Differences in the degree and rate of absorption of Dimension New®) in healthy adult populations to evaluate its bioequivalence.
Secondary purpose: To evaluate the efficacy of agomelatine tablets (25 mg) provided by Shenyang Funing Pharmaceutical Co., Ltd. and agomelatine tablets (25 mg, trade name) licensed by Les Laboratoires Servier under fasting and postprandial administration conditions. : Dimension New®) safety in healthy adults.