[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence trial evaluating the investigational formulation Leborexen tablets (5 mg) versus the reference formulation (Dayvigo®) (5 mg) in healthy adult participants in fasting condition.
主要试验目的:研究空腹状态下单次口服受试制剂莱博雷生片(规格:5 mg,江苏宣泰药业有限公司生产)与参比制剂莱博雷生片(Dayvigo®,规格:5 mg;EISAI MANUFACTURING Ltd生产)在健康参与者体内的药代动力学特征,评价空腹状态口服两种制剂的生物等效性。次要试验目的:研究受试制剂莱博雷生片(规格:5 mg)和参比制剂莱博雷生片(Dayvigo®)(规格:5 mg)在健康参与者中的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic characteristics of a single oral dose of the test formulation, Lebrexone tablets (5 mg, manufactured by Jiangsu Xuantai Pharmaceutical Co., Ltd.), and the reference formulation, Lebrexone tablets (Dayvigo®, 5 mg; manufactured by EISAI MANUFACTURING Ltd.), in healthy participants under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting oral administration. Secondary objective: To investigate the safety of the test formulation, Lebrexone tablets (5 mg), and the reference formulation, Lebrexone tablets (Dayvigo®) (5 mg), in healthy participants.