Pharmacokinetics And Bioequivalence Of Omeprazole Capsules

Objective:To develop a method for determination of omeprazole and its two metabolites (5-hydroxyomeprazole and omeprazole sulfone) in human plasma by HPLC, and study its pharmacokinetics and bioequvalence in Chinese healthy volunteers. Extract and purify the omeprazole metabolites in human urine, and applied to study its metabolism on extensive metabilizers and poor metabolizers in human body.Methods:A randomized two-way cross-over study design was adopted in the study. The 24 volunteers were randomLy divided in to two groups equally. The plasma concentration of omeprazole capsules were determined by HPLC after a single oral dose of 40mg of two omeprazole formulations respectively, the results were analyzed by program DAS(Drug And Statistic ver 2.0).Metabolites of omeprazole were extracted and purified from human urine samples, then the two metabolites concentrations in plasma were determined by HPLC after a single oral dose of 40mg omepazole capsules in 24 Volunteers. Metabolic ratio (MR) in different time after administration were available which equaled to the ratio of omeprazole and 5-hydroxy omeprazole plasma concetration. All subjects were divided into Extensive Metabolizers (EMs) and Poor Metabolizers (PMs) according to MR, then parmacokinetic parameters were estimated between different phenotype.