[Translation] A randomized, open-label, multiple-dose, two-period, crossover controlled PK/PD and safety study of LJ01003 capsules and omeprazole magnesium enteric-coated tablets (Losec MUPS) in healthy Chinese adults
在中国健康成年受试者中,以长春澜江医药科技有限公司的LJ01003胶囊为受试制剂,阿斯利康制药有限公司生产的奥美拉唑镁肠溶片(洛赛克MUPS)为参比制剂,评价两种制剂药代动力学及药效动力学的生物等效性、食物对受试制剂药代动力学参数的影响、受试制剂与参比制剂不同剂量给药的药代动力学参数对比,以及安全性和耐受性。
[Translation] Methods: In healthy adult subjects in China, LJ01003 capsules produced by Changchun Lanjiang Pharmaceutical Technology Co., Ltd. were used as the test preparation, and omeprazole magnesium enteric-coated tablets (Losec MUPS) produced by AstraZeneca Pharmaceuticals Co., Ltd. were used as the reference preparation. The pharmacokinetics and pharmacodynamics bioequivalence of the two preparations, the effect of food on the pharmacokinetic parameters of the test preparation, the comparison of pharmacokinetic parameters of the test preparation and the reference preparation at different doses, as well as the safety and tolerability were evaluated.