[Translation] A randomized, open-label, single-dose, two-cycle, double-crossover bioequivalence trial of merogabarine besylate tablets in healthy adult participants in both fasting and postprandial states.
主要研究目的:研究空腹和餐后状态下单次口服受试制剂苯磺酸美洛加巴林片(规格:5mg,生产厂家:南京正科医药股份有限公司)和参比制剂苯磺酸美洛加巴林片(商品名:德力静®,规格:5mg,持证商:DAIICHI SANKYO CO., LTD.)在健康参与者体内的药代动力学特征,并评价两制剂的人体生物等效性。
次要研究目的:观察受试制剂苯磺酸美洛加巴林片和参比制剂(德力静®)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 merogabarine besylate tablets (5 mg, manufactured by Nanjing Zhengke Pharmaceutical Co., Ltd.) and the reference formulation merogabarine besylate tablets (trade name: Delijing®, 5 mg, licensee: DAIICHI SANKYO CO., LTD.) in healthy participants under fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations in humans.
Secondary objective: To observe the safety of the test formulation merogabarine besylate tablets and the reference formulation (Delijing®) in healthy participants.