奥美拉唑肠溶胶囊人体生物等效性临床研究  

Clinical studies on human bioequivalence of omeprazole enteric-coated capsules

作　　者：茅关兴 赵丽敏 李琦君 徐诗强[4] MAO Guanxing;ZHAO Limin;LI Qijun;XU Shiqiang(Shanghai Pharmaceutical Industry Co.,Ltd.,Shanghai 200002,China;Shanghai Meiyou Pharmaceutical Co.,Ltd.,Shanghai 201422,China;Shenyang Dasan Pharmaceutical Technology Co.,Ltd.,Shenyang 110179,China;School of Medicine,Wuhan University of Science and Technology,Wuhan 430065,China)

机构地区：[1]上海医药工业有限公司,上海200002 [2]上海美优制药有限公司,上海201422 [3]沈阳达善医药科技有限公司,沈阳110179 [4]武汉科技大学医学院,武汉430065

出　　处：《上海医药》2024年第15期78-82,共5页Shanghai Medical & Pharmaceutical Journal

基　　金：上海市战略性新兴产业发展专项资金资助项目。

摘　　要：评估自制奥美拉唑肠溶胶囊(20 mg)与参比制剂(LOSEC,20 mg)在体内的生物等效性。受试者均为健康成人,盲法随机服用自制制剂或参比制剂的奥美拉唑肠溶胶囊。通过测定血浆中奥美拉唑的浓度,以药代动力学参数为指标比较两种制剂的生物等效性,并评价两制剂体内安全性。结果显示,在空腹及餐后条件下,自制制剂与参比制剂的奥美拉唑药动学参数几何均数比值均落在生物等效性接受范围内,具有生物等效性,不良事件发生率相近,所有不良反应均为轻度,安全性无显著差异。To evaluate the bioequivalence of generic omeprazole enteric-coated capsules(20 mg)versus a reference formulation(LOSEC,20 mg)in vivo.Healthy adult subjects were enrolled and randomly and blindly administered with either the generic formulation or the reference formulation of omeprazole enteric-coated capsules.By measuring the concentration of omeprazole in plasma,the bioequivalence of the two formulations was compared using pharmacokinetic parameters and their in vivo safety was evaluated.The results showed that under fasting and postprandial conditions,the geometric mean ratio of pharmacokinetic parameters of the two preparations fell within the acceptance range of bioequivalence,the adverse reactions associated with generic preparation were mild and similar to those of reference formulation,and there were no distinctive differences in safety between the two preparations.

关 键 词：奥美拉唑 肠溶胶囊 一致性评价 生物等效性 

分 类 号：R969.4[医药卫生—药理学] R975.2[医药卫生—药学]