A randomized comparative study to determine the effect of omeprazole on the peak serum concentration of itraconazole oral solution.
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.
Johnson
Melissa D
MD
Division of Infectious Diseases and International Health, Duke University Medical Center, Box 3306 DUMC, Durham, NC 27710, USA. johns200@mc.duke.edu
Hamilton
Carol D
CD
Drew
Richard H
RH
Sanders
Linda L
LL
Pennick
Gennethel J
GJ
Perfect
John R
JR
D000293:Adolescent; D000328:Adult; D000897:Anti-Ulcer Agents / Q000494:pharmacology*; D000935:Antifungal Agents / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001711:Biotransformation; D004347:Drug Interactions; D005260:Female; D006801:Humans; D017964:Itraconazole / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000494:pharmacology*; D019999:Pharmaceutical Solutions
D000897:Anti-Ulcer Agents; D000935:Antifungal Agents; D019999:Pharmaceutical Solutions; D017964:Itraconazole; D009853:Omeprazole