[Translation] Evaluate the single-center, open-label, randomized, single-center, open-label, single-center, open-label, single-center, open-labeled, single-center, open-label, single-center, open-label, study of the test preparation esomeprazole magnesium enteric-coated capsules (specification: 40 mg) and the reference preparation NEXIUM® (specification: 40 mg) in healthy adult subjects in the fasting state. Dose, two-cycle, two-sequence, crossover bioequivalence studies
1、主要研究目的:研究空腹状态下单次口服受试制剂艾司奥美拉唑镁肠溶胶囊(规格:40 mg,浙江金华康恩贝生物制药有限公司生产)与参比制剂艾司奥美拉唑镁肠溶胶囊(NEXIUM®,规格:40 mg,AstraZeneca Pharmaceuticals Lp生产)在健康受试者体内的药代动力学,评价空腹状态下口服两种制剂的生物等效性。
2、次要研究目的:评估受试制剂艾司奥美拉唑镁肠溶胶囊(规格:40 mg)和参比制剂艾司奥美拉唑镁肠溶胶囊(NEXIUM®,规格:40 mg)在健康受试者中的安全性。
[Translation] 1. Main research purpose: To study the single oral administration of the test preparation esomeprazole magnesium enteric-coated capsules (specification: 40 mg, produced by Zhejiang Jinhua Conba Biopharmaceutical Co., Ltd.) and the reference preparation esomeprazole in a fasting state. Pharmacokinetics of meprazole magnesium enteric-coated capsules (NEXIUM®, strength: 40 mg, produced by AstraZeneca Pharmaceuticals Lp) in healthy subjects to evaluate the bioequivalence of the two oral preparations in the fasting state.
2. Secondary research purpose: To evaluate the test preparation esomeprazole magnesium enteric-coated capsules (specification: 40 mg) and the reference preparation esomeprazole magnesium enteric-coated capsules (NEXIUM®, specification: 40 mg) Safety in healthy subjects.