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Clinical Trial
. 2003 Feb;51(2):453-7.
doi: 10.1093/jac/dkg089.

A randomized comparative study to determine the effect of omeprazole on the peak serum concentration of itraconazole oral solution

Melissa D Johnson  1 , Carol D Hamilton, Richard H Drew, Linda L Sanders, Gennethel J Pennick, John R Perfect
Affiliations
Clinical Trial

A randomized comparative study to determine the effect of omeprazole on the peak serum concentration of itraconazole oral solution

Melissa D Johnson et al. J Antimicrob Chemother. 2003 Feb.

Abstract

To determine the effect of omeprazole on peak serum concentrations (C(max)) of itraconazole oral solution (IOS), we carried out a randomized, open-label, prospective, crossover study. Fifteen healthy, non-pregnant adults received a single dose of IOS 400 mg on two occasions, at least 7 days apart, with omeprazole 40 mg nightly for 7 days before either IOS dose 1 or 2. C(max), time to C(max) (T(max)) and AUC(0-8) were determined for itraconazole and its active metabolite, hydroxyitraconazole, for each dose and compared. Omeprazole did not significantly affect the C(max), T(max) or AUC(0-8) of itraconazole or hydroxyitraconazole when administered as IOS.

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Figures

Figure 1
Figure 1
Mean serum itraconazole and hydroxyitraconazole concentration–time curves. Dashed lines, itraconazole serum concentrations; solid lines, hydroxyitraconazole serum concentrations; circles, reference treatment (IOS alone); squares, test treatment (IOS + omeprazole).
See this image and copyright information in PMC

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