title: A randomized comparative study to determine the effect of omeprazole on the peak serum concentration of itraconazole oral solution.
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.
authors.affiliation: Division of Infectious Diseases and International Health, Duke University Medical Center, Box 3306 DUMC, Durham, NC 27710, USA. johns200@mc.duke.edu
authors.forename: Melissa D
authors.initials: MD
authors.lastname: Johnson
authors.forename: Carol D
authors.initials: CD
authors.lastname: Hamilton
authors.forename: Richard H
authors.initials: RH
authors.lastname: Drew
authors.forename: Linda L
authors.initials: LL
authors.lastname: Sanders
authors.forename: Gennethel J
authors.initials: GJ
authors.lastname: Pennick
authors.forename: John R
authors.initials: JR
authors.lastname: Perfect
mesh_terms: 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
chemical_list: D000897:Anti-Ulcer Agents; D000935:Antifungal Agents; D019999:Pharmaceutical Solutions; D017964:Itraconazole; D009853:Omeprazole