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JAC Advance Access published online on January 14, 2003
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkg089
© 2003 by The British Society for Antimicrobial Chemotherapy
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© 2003 The British Society for Antimicrobial Chemotherapy

Brief report

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 1, Richard H. Drew 1, Linda L. Sanders 2, Gennethel J. Pennick 3, John R. Perfect 4

1 Division of Infectious Diseases and International Health, Duke University Medical Center, Box 3306 DUMC, Durham, NC 27710
2 Department of Medicine, Duke University Medical Center, Box 3827 DUMC, Durham, NC 27710
3 Fungus Testing Laboratory, Department of Pathology, University of Texas Health Science Center, San Antonio, TX 78284
4 Division of Infectious Diseases and International Health, Duke University Medical Center, Box 3306 DUMC, Durham, NC 27710; Department of Microbiology, Duke University Medical Center, Box 3353 DUMC, Durham, NC 27710, USA

* Corresponding author. E-mail: johns200{at}mc.duke.edu.

Received 21 June 2002 ; revised 4 November 2002 ; accepted 19 November 2002

Abstract

To determine the effect of omeprazole on peak serum concentrations (Cmax) 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. Cmax, time to Cmax (Tmax) and AUC0-8 were determined for itraconazole and its active metabolite, hydroxyitraconazole, for each dose and compared. Omeprazole did not significantly affect the Cmax, Tmax or AUC0-8 of itraconazole or hydroxyitraconazole when administered as IOS.

Keywords: itraconazole, pharmacokinetics, omeprazole
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