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Effect of timing of dosing in relation to food intake on the pharmacokinetics of esomeprazole.

Author(s): Sostek MB, Chen Y, Andersson T

Affiliation(s): AstraZeneca LP, Wilmington, DE, USA. mark.sostek@astrazeneca.com

Publication date & source: 2007-09, Br J Clin Pharmacol., 64(3):386-90. Epub 2007 Apr 10.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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.

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