[Translation] A single-center, open-label, randomized, single-dose, four-period, two-sequence, fully replicated, crossover bioequivalence trial evaluating the investigational formulation, etorizine hydrochloride tablets (50 mg), and the reference formulation, Myona® (50 mg), in healthy adult participants under fasting and postprandial conditions.
主要研究目的:研究空腹和餐后状态下单次口服受试制剂盐酸乙哌立松片(规格:50 mg,辰欣药业股份有限公司生产)与参比制剂盐酸乙哌立松片(妙纳®,规格:50 mg,卫材(中国)药业有限公司持证)在健康成年试验参与者体内的药代动力学,评价空腹和餐后状态下口服两种制剂的生物等效性。
次要研究目的:评估受试制剂盐酸乙哌立松片(规格:50 mg)和参比制剂盐酸乙哌立松片(妙纳®,规格:50 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, eperisone hydrochloride tablets (50 mg, manufactured by Chenxin Pharmaceutical Co., Ltd.), and the reference formulation, eperisone hydrochloride tablets (Miaona®, 50 mg, certified by Eisai (China) Pharmaceutical Co., Ltd.), in healthy adult participants under both 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, eperisone hydrochloride tablets (50 mg), and the reference formulation, eperisone hydrochloride tablets (Miaona®, 50 mg), in healthy adult participants.