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CLC number: R969.1

On-line Access: 2012-05-04

Received: 2011-08-22

Revision Accepted: 2012-01-18

Crosschecked: 2012-04-06

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Citations:  Bibtex RefMan EndNote GB/T7714

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Journal of Zhejiang University SCIENCE B 2012 Vol.13 No.5 P.348-355

http://doi.org/10.1631/jzus.B1100272


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


Author(s):  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

Affiliation(s):  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; more

Corresponding email(s):   stjz@zju.edu.cn

Key Words:  Omeprazole, 5-Hydroxyomeprazole, Omeprazole sulfone, Bioavailability, Pharmacokinetics, Liquid chromatography/tandem mass spectrometry (LC-MS/MS)


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[J]. Journal of Zhejiang University Science B, 2012, 13(5): 348-355.

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author="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",
journal="Journal of Zhejiang University Science B",
volume="13",
number="5",
pages="348-355",
year="2012",
publisher="Zhejiang University Press & Springer",
doi="10.1631/jzus.B1100272"
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%T Relative bioavailability and pharmacokinetic comparison of two different enteric formulations of omeprazole
%A Jian Liu
%A Jian-zhong Shentu
%A Li-hua Wu
%A Jing Dou
%A Qi-yang Xu
%A Hui-li Zhou
%A Guo-lan Wu
%A Ming-zhu Huang
%A Xing-jiang Hu
%A Jun-chun Chen
%J Journal of Zhejiang University SCIENCE B
%V 13
%N 5
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%@ 1673-1581
%D 2012
%I Zhejiang University Press & Springer
%DOI 10.1631/jzus.B1100272

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T1 - Relative bioavailability and pharmacokinetic comparison of two different enteric formulations of omeprazole
A1 - Jian Liu
A1 - Jian-zhong Shentu
A1 - Li-hua Wu
A1 - Jing Dou
A1 - Qi-yang Xu
A1 - Hui-li Zhou
A1 - Guo-lan Wu
A1 - Ming-zhu Huang
A1 - Xing-jiang Hu
A1 - Jun-chun Chen
J0 - Journal of Zhejiang University Science B
VL - 13
IS - 5
SP - 348
EP - 355
%@ 1673-1581
Y1 - 2012
PB - Zhejiang University Press & Springer
ER -
DOI - 10.1631/jzus.B1100272


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.

Darkslateblue:Affiliate; Royal Blue:Author; Turquoise:Article

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