[Translation] To evaluate the single-center, open-label, randomized, single-dose, two-cycle, two-sequence, crossover between the test formulation Esomeprazole Magnesium Enteric-Coated Capsules and the reference formulation in healthy adult subjects in the fasting (applesauce) state Bioequivalence Studies
主要试验目的:研究空腹(苹果酱撒布)状态下单次口服受试制剂艾司奥美拉唑镁肠溶胶囊(规格:40mg,浙江尖峰药业有限公司生产)与参比制剂艾司奥美拉唑镁肠溶胶囊(NEXIUM®,规格 40mg;AstraZeneca AB生产)在健康受试者体内的药代动力学特征,评价空腹(苹果酱撒布)状态口服两种制剂的生物等效性。次要试验目的:研究受试制剂艾司奥美拉唑镁肠溶胶囊(规格:40mg)和参比制剂艾司奥美拉唑镁肠溶胶囊(NEXIUM®)(规格:40mg)在健康受试者中的安全性。
[Translation] Main test purpose: To study the test preparation Esomeprazole Magnesium Enteric-Coated Capsules (specification: 40mg, produced by Zhejiang Jianfeng Pharmaceutical Co., Ltd.) and the reference preparation Esomeprazole in a single oral dose in the state of fasting (sprinkled with applesauce). Pharmacokinetic characteristics of prazole magnesium enteric-coated capsules (NEXIUM®, strength 40 mg; manufactured by AstraZeneca AB) in healthy subjects, evaluating the bioequivalence of two oral preparations in the fasting (applesauce) state. Secondary trial objectives: To study the efficacy of the test preparation esomeprazole magnesium enteric-coated capsules (specification: 40 mg) and the reference preparation esomeprazole magnesium enteric-coated capsules (NEXIUM®) (specification: 40 mg) in healthy subjects. safety in test subjects.