Relative bioavailability and pharmacokinetic comparison of two different enteric formulations of omeprazole.

Journal of Zhejiang University. Science. B
Jian LiuJun-chun Chen

Abstract

In order to comply with the requirements for a drug listed in China, the study was developed to compare the pharmacokinetics and relative bioavailability of two different enteric formulations of omeprazole (OPZ) in healthy Chinese subjects. A total of 32 volunteers participated in the study. Plasma concentrations were analyzed by nonstereospecific liquid chromatography/tandem mass spectrometric (LC-MS/MS) method. After administration of a single 40-mg dose of the two OPZ formulations, the comparative bioavailability was assessed by calculating individual AUC(0‒t) (the area under the concentration-time curve from time zero to the last measurable concentration), AUC(0‒∞) (the area under the concentration-time curve extrapolated to infinity), C(max) (the maximum observed concentration), and T(peak) (the time to C(max)) values of OPZ, 5-hydroxyomeprazole (OH-OPZ), and omeprazole sulfone (OPZ-SFN), respectively. The 90% confidence intervals (CIs) of AUC(0‒t), AUC(0‒∞), and C(max) were 85.4%‒99.0%/88.8%‒98.6%/87.6%‒99.4%, 85.5%‒99.2%/89.0%‒98.6%/88.5%‒101.3%, and 72.3%‒87.6%/79.6%‒91.1%/88.4%‒99.1% for OPZ/OH-OPZ/OPZ-SFN, respectively, and T(peak) values did not differ significantly. In this study, the test formulation of OPZ in fast...Continue Reading

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