[Translation] Dotenoradine tablets (2 mg) were subject to a randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence pre-trial in Chinese health study participants under fasting and postprandial dosing conditions.
主要研究目的:按有关生物等效性试验的规定,选择FUJI YAKUHIN CO., LTD.为持证商的多替诺雷片(商品名:优乐思,规格:2mg)为参比制剂,对华润双鹤利民药业(济南)有限公司生产,华润双鹤利民药业(济南)有限公司提供的受试制剂多替诺雷片(规格:2mg)进行空腹和餐后给药人体生物等效性预试验,估算空腹和餐后给药后受试制剂和参比制剂的药代动力学特征,为正式试验的设计提供一定的参考依据。
次要研究目的:观察健康研究参与者口服受试制剂多替诺雷片(规格:2mg)和参比制剂多替诺雷片(商品名:优乐思,规格:2mg)的安全性。
[Translation] Primary research objective: In accordance with relevant bioequivalence testing regulations, domenorrhea tablets (trade name: Ulexi, strength: 2mg), manufactured by FUJI YAKUHIN CO., LTD., a licensee, were selected as the reference formulation. A preliminary human bioequivalence study was conducted on domenorrhea tablets (strength: 2mg), manufactured by and supplied by CR Double-Crane Limin Pharmaceutical (Jinan) Co., Ltd., under fasting and postprandial administration. The pharmacokinetic characteristics of the test and reference formulations after fasting and postprandial administration were estimated to provide a reference for the design of the formal trial.
Secondary research objective: To observe the safety of oral administration of the test and reference formulations, domenorrhea tablets (strength: 2mg), to healthy participants.