[Translation] A randomized, open-label, fasting and postprandial, single-dose, two-formulation, four-period, fully replicated crossover bioequivalence study of ilaprazole enteric-coated tablets in healthy individuals.
主要研究目的 研究空腹和餐后状态下单次口服受试制剂艾普拉唑肠溶片(规格:5mg,广东安诺药业股份有限公司提供)与参比制剂艾普拉唑肠溶片(壹丽安®,规格:5mg,丽珠集团丽珠制药厂持证)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口服两种制剂的生物等效性。
次要研究目的 研究受试制剂艾普拉唑肠溶片和参比制剂艾普拉唑肠溶片(壹丽安®)在健康成年受试者中的安全性。
[Translation] Primary Objective: To investigate the pharmacokinetics of a single oral dose of the test formulation, esomeprazole enteric-coated tablets (5 mg, provided by Guangdong Annoroad Pharmaceutical Co., Ltd.), and the reference formulation, esomeprazole enteric-coated tablets (Yilian®, 5 mg, certified by Livzon Pharmaceutical Factory, Livzon Group), in healthy adult subjects under both fasting and postprandial conditions, and to evaluate the bioequivalence of the two formulations under fasting and postprandial administration.
Secondary Objective: To investigate the safety of the test formulation, esomeprazole enteric-coated tablets, and the reference formulation, esomeprazole enteric-coated tablets (Yilian®), in healthy adult subjects.