Relative bioavailability and pharmacokinetic comparison of two different enteric formulations of omeprazole |
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| Authors: | Jian Liu Jian-zhong Shentu Li-hua Wu Jing Dou Qi-yang Xu Hui-li Zhou Guo-lan Wu Ming-zhu Huang Xing-jiang Hu and Jun-chun Chen |
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| Institution: | 1State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, Infectious Disease Center, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China;2Research Center for Clinical Pharmacy, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China |
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| 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 AUC0−t
(the area under the concentration-time curve from time zero to the last measurable concentration), AUC0−∞ (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 AUC0−t
, AUC0−∞, 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 fasting healthy Chinese male volunteers
met the Chinese bioequivalance standard to the reference formulation based on AUC, C
max, and T
peak. |
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| Keywords: | Omeprazole 5-Hydroxyomeprazole Omeprazole sulfone Bioavailability Pharmacokinetics Liquid chromatography/tandem mass spectrometry (LC-MS/MS) |
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