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薬理と治療
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Abstract
Cilostazol orally disintegrated tablets(ODT)are a newly developed formulation for easierswallowing by patients with swallowing disorders that make it difficult for them to take tabletswith water. The bioequivalence of one cilostazol 100−mg ODT ingested with or withoutwater and one cilostazol 100−mg conventional tablet ingested with water was evaluated inhealthy adult male subjects in an open−label, randomized, 2−formulation, 2−treatment, 3−period crossover study.Thirty six subjects were enrolled, and 32 subjects completed the study. The differencesin the mean log−transformed AUC60h and Cmax values between the ODT without water andthe conventional tablet(ODT without water−conventional tablet, point estimates)were bothlog(0.94), with respective 90% confidence intervals of log(0.88)to log(1.00)and log(0.87)to log(1.02). The differences in the mean log−transformed AUC60h and Cmax valuesbetween the ODT with water and the conventional tablet(ODT with water−conventionaltablet, point estimates)were both log(0.98), with respective 90% confidence intervals of log(0.92)to log(1.04)and log(0.91)to log(1.06). All values were within the range of the equivalencejudgment criteria of log(0.8)to log(1.25)specified in the guideline for bioequivalencestudies.Based on the above results, one cilostazol 100−mg ODT, when administered either withor without water, was judged to be bioequivalent to one cilostazol 100−mg conventional tablet.All adverse events observed in all groups were mild or moderate in severity and wereresolved. Deaths or other serious adverse events or clinically significant adverse events didnot occur.(Jpn Pharmacol Ther 2009;37:805−12)KEY WORDS Cilostazol, Antithrombotic drug, Healthy adult male subjects, Orally disintegratedtablets, Bioequivalence
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