[Translation] A single-center, open-label, randomized, single-dose, two-period, two-crossover bioequivalence trial of dotenoradine tablets in healthy study participants in both fasting and postprandial states.
主要目的:比较空腹和餐后给药条件下,杭州和康药业有限公司提供的多替诺雷片(2mg)与株式会社富士薬品持证的多替诺雷片(2mg,商品名:URECE®)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,杭州和康药业有限公司提供的多替诺雷片(2mg)与株式会社富士薬品持证的多替诺雷片(2mg,商品名:URECE®)在健康成年人群中的安全性。
[Translation] Primary objective: To compare the absorption rate and extent of dotenorazole tablets (2 mg) supplied by Hangzhou Hekang Pharmaceutical Co., Ltd. with that of dotenorazole tablets (2 mg, brand name: URECE®) certified by Fuji Pharmaceutical Co., Ltd. in a healthy adult population under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary objective: To evaluate the safety of dotenorazole tablets (2 mg) supplied by Hangzhou Hekang Pharmaceutical Co., Ltd. with that of dotenorazole tablets (2 mg, brand name: URECE®) certified by Fuji Pharmaceutical Co., Ltd. in a healthy adult population under fasting and postprandial administration conditions.