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Effect of timing of dosing in relation to food intake on the pharmacokinetics of esomeprazole
Author(s) -
Sostek Mark B.,
Chen Yusong,
Andersson Tommy
Publication year - 2007
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/j.1365-2125.2007.02889.x
Subject(s) - esomeprazole , meal , crossover study , bioavailability , bioequivalence , pharmacokinetics , dosing , medicine , calorie , zoology , pharmacology , biology , alternative medicine , pathology , placebo
What is already known about this subject Systemic esomeprazole exposure is decreased when administered simultaneously with food. What this study adds Taking esomeprazole within 15 min of eating a high‐fat, high‐calorie meal results in reduced systemic drug exposure. 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.