[Translation] A preliminary bioequivalence study of dotenoradine tablets in healthy study participants under fasting and postprandial conditions, using a randomized, open-label, two-sequence, two-period, crossover design.
主要目的:研究空腹和餐后状态下,单次口服多替诺雷片受试制剂(T,规格:2mg,江苏海岸药业有限公司)与参比制剂(R,商品名:URECE®,规格:2mg,株式会社富士薬品)在健康研究参与者中的药代动力学行为,评价两制剂的生物等效性趋势,为正式试验提供依据。次要目的:评价受试制剂多替诺雷片和参比制剂URECE®在健康研究参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic behavior of the test formulation (T, strength: 2 mg, Jiangsu Coast Pharmaceutical Co., Ltd.) and the reference formulation (R, trade name: URECE®, strength: 2 mg, Fuji Pharmaceutical Co., Ltd.) after a single oral dose in healthy study participants under fasting and postprandial conditions, to evaluate the bioequivalence trend of the two formulations, and to provide a basis for formal trials. Secondary objective: To evaluate the safety of the test formulation docenolactone tablets and the reference formulation URECE® in healthy study participants.