Bioequivalence of granisetron HCl orally disintegrating tablet in Chinese healthy volunteers

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:C_max=(7.2±3.4)μg/L,t_1/2=(4.2±1.8)h,t_max=(1.3±0.3)h,AUC_0~24 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.