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薬理と治療
Abstract
Background Itraconazole(ITCZ)oral solution(−os)is more effective than ITCZ capsulefor fungal infection. However, some patients refuse it due to unpleasant taste.Objectives The aim of this study was to evaluation the influence of ITCZ−os dilution withdistilled water(DW)or simple syrup on the pharmacokinetics property of ITCZ and it’smetabolite and on taste.Methods Each of 12 healthy male volunteers were enrolled in 2 independent studies.ITCZ−os was diluted with same amount of DW or simple syrup at dispensation and singledosed as 200 mg of ITCZ. Pharmacokinetics of ITCZ+DW and ITCZ+syrup were comparedwith ITCZ−os using cross over design.Results Cmax and AUC0→24 of ICTZ, OH−ITCZ and actives diluted with DW or syrup werebioequivalent with ITCZ−os. The score of bitter was slightly improved in ITCZ+DW and significantlyimproved in ITCZ+syrup(p=0.005 and p=0.001, respectively).Conclusions Dilution of ITCZ−os with DW or syrup had no affect on pharmacokineticsproperty. The dilution with syrup will be helpful for compliance who felt unpleasant taste.(Jpn Pharmacol Ther 2009;37:307−14)KEY WORDS Itraconazole oral solution, Dilution, Pharmacokinetics, Bioequivalence, Taste
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