[Translation] To evaluate the effect of the test preparation Shandong Yikang Pharmaceutical Omeprazole Sodium Bicarbonate Dry Suspension (Ⅰ) 20mg/1680mg and the reference preparation Salix Omeprazole Sodium Bicarbonate Dry Suspension 20mg/1680mg on healthy adult patients. A single-center, open-label, randomized, single-dose, two-cycle, two-sequence, crossover bioequivalence study of subjects in the fasting state
主要研究目的:研究空腹状态下单次口服受试制剂奥美拉唑碳酸氢钠干混悬剂(Ⅰ)(规格:每袋含奥美拉唑20mg与碳酸氢钠1680mg,山东益康药业股份有限公司生产)与参比制剂奥美拉唑碳酸氢钠干混悬剂(商品名ZEGERID,规格:每袋含奥美拉唑20mg与碳酸氢钠1680mg;Salix Pharmaceuticals Inc产品)在健康受试者体内的药代动力学,评价空腹状态口服两种制剂的生物等效性。
次要研究目的:研究受试制剂参比制剂在健康受试者中的安全性。
[Translation] Main research purpose: To study a single oral dose of the test preparation omeprazole sodium bicarbonate dry suspension (Ⅰ) in fasting state (specification: each bag contains omeprazole 20mg and sodium bicarbonate 1680mg, Shandong Yikang Pharmaceutical Co., Ltd. Co., Ltd.) and the reference preparation omeprazole sodium bicarbonate dry suspension (trade name ZEGERID, specification: each bag contains omeprazole 20mg and sodium bicarbonate 1680mg; Salix Pharmaceuticals Inc product) in healthy subjects The pharmacokinetics of the two formulations were evaluated in the fasting state and the bioequivalence of the two formulations was evaluated.
Secondary research objectives: To study the safety of the test preparation and the reference preparation in healthy subjects.