[Translation] A formal trial of a randomized, open-label, single-dose, two-drug, crossover design to evaluate the bioequivalence of a single oral dose of the test formulation, trimebutine maleate tablets, and the reference formulation, trimebutine maleate tablets (trade name: Debridat®), in healthy Chinese subjects in the fasting and fed state
主要目的:研究空腹及餐后状态下单次口服受试制剂马来酸曲美布汀片(规格:0.2g/片,浙江东亚药业股份有限公司生产)与参比制剂马来酸曲美布汀片(Debridat®,规格:200mg/片;FARMEA生产)在健康受试者体内的药代动力学,评价空腹及餐后状态口服两种制剂的生物等效性。
次要目的:研究受试制剂马来酸曲美布汀片和参比制剂马来酸曲美布汀片在健康受试者中的安全性。
[Translation] Primary objective: To study the pharmacokinetics of the test preparation trimebutine maleate tablets (specification: 0.2g/tablet, produced by Zhejiang East Asia Pharmaceutical Co., Ltd.) and the reference preparation trimebutine maleate tablets (Debridat®, specification: 200mg/tablet; produced by FARMEA) in healthy subjects after single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in fasting and fed state.
Secondary objective: To study the safety of the test preparation trimebutine maleate tablets and the reference preparation trimebutine maleate tablets in healthy subjects.