{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T00:45:03Z","timestamp":1761093903327,"version":"build-2065373602"},"reference-count":24,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2012,1,16]],"date-time":"2012-01-16T00:00:00Z","timestamp":1326672000000},"content-version":"vor","delay-in-days":2846,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accpjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacotherapy"],"published-print":{"date-parts":[[2004,4]]},"abstract":"<jats:p><jats:bold>Study Objective.<\/jats:bold> To evaluate the effect of repeated ingestion of grapefruit juice on the systemic availability of itraconazole (ITZ) and hydroxy\u2010itraconazole (OHITZ) serum concentrations in subjects administered hydroxypropyl\u2010\u03b2\u2010cyclodextrin\u2010ITZ (HP\u2010\u03b2\u2010CD ITZ) oral solution.<\/jats:p><jats:p><jats:bold>Design.<\/jats:bold> Randomized, two\u2010period, crossover study.<\/jats:p><jats:p><jats:bold>Setting.<\/jats:bold> College of pharmacy research unit.<\/jats:p><jats:p><jats:bold>Subjects.<\/jats:bold> Twenty healthy, adult volunteers (10 men, 10 women).<\/jats:p><jats:p><jats:bold>Intervention.<\/jats:bold> Subjects received 240 ml of regular\u2010strength grapefruit juice from frozen concentrate or bottled purified water 3 times\/day for 2 days. On the third day they received a single dose of HP\u2010\u03b2\u2010CD ITZ oral solution 200 mg (20 ml) with 240 ml of the beverage. Two hours after dosing they received another 240 ml of the beverage.<\/jats:p><jats:p><jats:bold>Measurements and Main Results.<\/jats:bold> Repeated blood samples were drawn for 72 hours after dosing. After a 14\u2010day washout period, subjects were crossed over to the beverage they had not received previously and the above procedure was repeated. There was no difference in peak ITZ concentration (C<jats:sub>max<\/jats:sub>) or time to C<jats:sub>max<\/jats:sub> (T<jats:sub>max<\/jats:sub>). Coadministration of grapefruit juice reduced OHITZ C<jats:sub>max<\/jats:sub> nearly 10%, but this difference was not statistically significant. It produced a statistically significant increase in ITZ area under the concentration\u2010time curves from 0\u201348 hours (AUC<jats:sub>0\u201348<\/jats:sub>) (17%) and from time zero extrapolated to infinity (AUC<jats:sub>0\u2013<\/jats:sub>) (19.5%). Apparent oral clearance of ITZ was significantly reduced (14%). Significant changes in OHITZ exposure were not observed; however, grapefruit juice coadministration produced statistically significant decreased mean OHITZ:ITZ AUC<jats:sub>0\u201348<\/jats:sub> and AUC<jats:sub>0\u2013<\/jats:sub> ratios. Grapefruit juice also decreased the mean OHITZ:ITZ C<jats:sub>max<\/jats:sub> ratio, but the difference was not statistically significant.<\/jats:p><jats:p><jats:bold>Conclusion.<\/jats:bold> Repeated grapefruit juice consumption moderately affects ITZ systemic availability in subjects administered HP\u2010\u03b2\u2010CD ITZ oral solution. Unlike previous findings with ITZ capsules, changes in the disposition of ITZ and OHITZ after repeated grapefruit juice consumption are consistent with grapefruit juice inhibition of intestinal cytochrome P450 3A4.<\/jats:p>","DOI":"10.1592\/phco.24.5.460.33350","type":"journal-article","created":{"date-parts":[[2004,5,25]],"date-time":"2004-05-25T04:52:13Z","timestamp":1085460733000},"page":"460-467","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Influence of Grapefruit Juice on the Systemic Availability of Itraconazole Oral Solution in Healthy Adult Volunteers"],"prefix":"10.1002","volume":"24","author":[{"given":"Paul O.","family":"Gubbins","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Scott A.","family":"McConnell","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bill 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