Document Detail


Effect of timing of dosing in relation to food intake on the pharmacokinetics of esomeprazole.
MedLine Citation:
PMID:  17425628     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIM: To investigate the pharmacokinetics of esomeprazole before a high-fat meal vs. fasting.
METHODS: This open-label, randomized, crossover study consisted of two 5-day dosing periods of esomeprazole 40 mg per day. On days 1 and 5, subjects received esomeprazole 15 min before a high-fat meal (fed) or 4 h before a non-high-fat meal (fasting).
RESULTS: On days 1 and 5, ratio of fed to fasting area under the plasma concentration-time curve [0.56, 90% confidence interval (CI) 0.50, 0.64, and 0.78, 90% CI 0.74, 0.82, respectively] and peak plasma concentration (0.34, 90% CI 0.28, 0.41, and 0.47, 90% CI 0.41, 0.52, respectively) were outside of the limits of bioequivalence.
CONCLUSIONS: Esomeprazole bioavailability was reduced when taken within 15 min before eating a high-fat meal vs. that while fasting.
Authors:
Mark B Sostek; Yusong Chen; Tommy Andersson
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2007-04-10
Journal Detail:
Title:  British journal of clinical pharmacology     Volume:  64     ISSN:  0306-5251     ISO Abbreviation:  Br J Clin Pharmacol     Publication Date:  2007 Sep 
Date Detail:
Created Date:  2007-08-24     Completed Date:  2008-01-17     Revised Date:  2013-01-07    
Medline Journal Info:
Nlm Unique ID:  7503323     Medline TA:  Br J Clin Pharmacol     Country:  England    
Other Details:
Languages:  eng     Pagination:  386-90     Citation Subset:  IM    
Affiliation:
AstraZeneca LP, Wilmington, DE, USA. mark.sostek@astrazeneca.com
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-Ulcer Agents / administration & dosage,  blood,  pharmacokinetics*
Area Under Curve
Biological Availability
Cross-Over Studies
Drug Administration Schedule
Eating*
Esomeprazole Sodium / administration & dosage,  blood,  pharmacokinetics*
Fasting
Female
Food-Drug Interactions
Humans
Male
Middle Aged
Chemical
Reg. No./Substance:
0/Anti-Ulcer Agents; L2C9GWQ43H/Esomeprazole Sodium
Comments/Corrections

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