2011•Journal of Bengbu Medical CollegeRequires access
Bioequivalence of granisetron HCl orally disintegrating tablet in Chinese healthy volunteers
Zhiwen Jiang
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Abstract
Objective:To study the pharmacokinetics of granisetron HCl orally disintegrating tablet and compare its relative bioavailability with domestic granisetron tablet.Methods:Twenty healthy volunteers were administered a single oral dose of domestic granisetron HCl orally disintegrating tablet or tablet(reference)in a randomized crossover study,and their plasma drug concentration was determined by HPLC-fluoremetry.Results:The plasma concentration-time curve was fitted to one-compartment model.The pharmacokinetic parameters obtained were:Cmax=(7.2±3.4)μg/L,t1/2 =(4.2±1.8)h,tmax =(1.3±0.3)h,AUC0~24 h=(37.3±25.6)μg·h·L.No significant difference was found between the test and the reference groups.The relative bioavailability obtained was(97.9±19.2)%.Conclusions:The two preparations are bioequivalent.