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JAC Advance Access originally published online on January 14, 2003
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Journal of Antimicrobial Chemotherapy (2003) 51, 453-457
© 2003 The British Society for Antimicrobial Chemotherapy

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

Melissa D. Johnson1,*, Carol D. Hamilton1, Richard H. Drew1, Linda L. Sanders2, Gennethel J. Pennick3 and John R. Perfect1,4

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 Department of Microbiology, Duke University Medical Center, Box 3353 DUMC, Durham, NC 27710, USA

Received 21 June 2002; returned 4 November 2002; revised 12 November 2002; accepted 19 November 2002

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

* Corresponding author. Tel: +1-919-684-2374; Fax: +1-919-681-7494; E-mail: johns200{at}mc.duke.edu


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