[Translation] A randomized, open-label, single-dose, two-formulation, crossover controlled bioequivalence study of omeprazole enteric-coated capsules in healthy subjects under fasting and fed conditions
主要目的:研究空腹及餐后状态下单次口服受试制剂奥美拉唑肠溶胶囊(规格:20mg,佛山手心制药有限公司生产)与参比制剂奥美拉唑肠溶胶囊(LOSEC®,规格:20mg;Neon Healthcare Ltd.公司持证)在健康成年受试者体内的药代动力学,评价空腹及餐后状态下口服两种制剂的生物等效性。
[Translation] Main objective: To study the pharmacokinetics of the test preparation Omeprazole Enteric-coated Capsules (Specification: 20 mg, produced by Foshan Shouxin Pharmaceutical Co., Ltd.) and the reference preparation Omeprazole Enteric-coated Capsules (LOSEC®, Specification: 20 mg; licensed by Neon Healthcare Ltd.) in healthy adult subjects after a single oral dose in fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in fasting and fed state.