Document Detail


Relative bioavailability and pharmacokinetic comparison of two different enteric formulations of omeprazole.
MedLine Citation:
PMID:  22556172     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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 fasting healthy Chinese male volunteers met the Chinese bioequivalance standard to the reference formulation based on AUC, C(max), and T(peak).
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; Jun-chun Chen
Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of Zhejiang University. Science. B     Volume:  13     ISSN:  1862-1783     ISO Abbreviation:  J Zhejiang Univ Sci B     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-05-04     Completed Date:  2012-09-10     Revised Date:  2013-06-25    
Medline Journal Info:
Nlm Unique ID:  101236535     Medline TA:  J Zhejiang Univ Sci B     Country:  China    
Other Details:
Languages:  eng     Pagination:  348-55     Citation Subset:  IM    
Affiliation:
State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, Infectious Disease Center, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-Ulcer Agents / blood,  chemistry,  pharmacokinetics
Biological Availability
Cross-Over Studies
Drug Compounding / methods
Humans
Metabolic Clearance Rate
Omeprazole / blood,  chemistry*,  pharmacokinetics*
Tablets, Enteric-Coated / chemistry*,  pharmacokinetics*
Young Adult
Chemical
Reg. No./Substance:
0/Anti-Ulcer Agents; 0/Tablets, Enteric-Coated; 73590-58-6/Omeprazole
Comments/Corrections

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