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

J Antimicrob Chemother. 2003 Feb;51(2):453-7. doi: 10.1093/jac/dkg089.


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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Anti-Ulcer Agents / pharmacology*
  • Antifungal Agents / blood
  • Antifungal Agents / pharmacokinetics*
  • Area Under Curve
  • Biotransformation
  • Drug Interactions
  • Female
  • Humans
  • Itraconazole / blood
  • Itraconazole / pharmacokinetics*
  • Male
  • Middle Aged
  • Omeprazole / pharmacology*
  • Pharmaceutical Solutions


  • Anti-Ulcer Agents
  • Antifungal Agents
  • Pharmaceutical Solutions
  • Itraconazole
  • Omeprazole