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ZJUS-B
Journal of Zhejiang University-SCIENCE B (Biomedicine & Biotechnology)  2012, Vol. 13 Issue (5): 348-355    DOI: 10.1631/jzus.B1100272
Articles     
Relative bioavailability and pharmacokinetic comparison of two different enteric formulations of omeprazole
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, Jun-chun Chen
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, Infectious Disease Center, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China; Research 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), Cmax (the maximum observed concentration), and Tpeak (the time to Cmax) values of OPZ, 5-hydroxyomeprazole (OH-OPZ), and omeprazole sulfone (OPZ-SFN), respectively. The 90% confidence intervals (CIs) of AUC0‒t, AUC0‒∞, and Cmax 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 Tpeak 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, Cmax, and Tpeak.

Key words： Omeprazole      5-Hydroxyomeprazole      Omeprazole sulfone      Bioavailability      Pharmacokinetics      Liquid chromatography/tandem mass spectrometry (LC-MS/MS)     
Received: 22 August 2011      Published: 04 May 2012
CLC:  R969.1  
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Jian Liu
Xing-jiang Hu
Jun-chun Chen
Jian-zhong Shentu
Li-hua Wu
Jing Dou
Qi-yang Xu
Hui-li Zhou
Guo-lan Wu
Ming-zhu Huang
Cite this article:

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, Jun-chun Chen. Relative bioavailability and pharmacokinetic comparison of two different enteric formulations of omeprazole. Journal of Zhejiang University-SCIENCE B (Biomedicine & Biotechnology), 2012, 13(5): 348-355.

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http://www.zjujournals.com/xueshu/zjus-b/10.1631/jzus.B1100272     OR     http://www.zjujournals.com/xueshu/zjus-b/Y2012/V13/I5/348

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