[Translation] A single-center, randomized, open-label, single-dose, two-period, two-sequence, crossover bioequivalence trial evaluating the investigational formulation docenolactone tablets (2 mg) and the reference formulation docenolactone tablets (URECE®, 2 mg) in healthy adult participants under fasting and postprandial conditions.
主要研究目的:研究空腹与餐后状态下单次口服受试制剂多替诺雷片(规格:2 mg,宁波美诺华天康药业有限公司生产)与参比制剂多替诺雷片(URECE ®,规格:2 mg,株式会社富士薬品生产)在健康成年试验参与者体内的药代动力学,评价空腹与餐后状态下口服两种制剂的生物等效性。
次要研究目的:评估受试制剂多替诺雷片(规格:2 mg)和参比制剂多替诺雷片(URECE®,规格:2 mg)在健康成年试验参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation domenorrhea tablets (2 mg, manufactured by Ningbo Minova Tiankang Pharmaceutical Co., Ltd.) and the reference formulation domenorrhea tablets (URECE®, 2 mg, manufactured by Fuji Pharmaceutical Co., Ltd.) in healthy adult participants under fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations under fasting and postprandial conditions.
Secondary objective: To evaluate the safety of the test formulation domenorrhea tablets (2 mg) and the reference formulation domenorrhea tablets (URECE®, 2 mg) in healthy adult participants.