[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test formulation, esomeprazole magnesium enteric-coated capsules, and the reference formulation in healthy adult subjects in the fasting state (apple sauce spread)
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] The primary objective of the study was to investigate the pharmacokinetic characteristics of the test preparation, esomeprazole magnesium enteric-coated capsules (specification: 40 mg, produced by Zhejiang Jianfeng Pharmaceutical Co., Ltd.) and the reference preparation, esomeprazole magnesium enteric-coated capsules (NEXIUM®, specification 40 mg; produced by AstraZeneca AB) in healthy subjects after a single oral administration under the fasting (apple sauce sprinkled) state, and to evaluate the bioequivalence of the two preparations when taken orally under the fasting (apple sauce sprinkled) state. The secondary objective of the study was to investigate the safety 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.