Evaluation of bioequivalence of granisetron HCl dispersible tablet

Objective: To study the pharmacokinetics and relative bioquivalence of granisetron HCl tablet and dispersible tablet. Methods: 12 healthy volunteers were treated with a single oral dose of domestic granisetron HCl dispersible tablet or tablet (control)in a randomized crossover study, and their plasma drug concentration were determined by HPLC. Results: The plasma concentration time curve was fitted to one compartment model. The pharmacokinetic parameters obtained were: C max =(7.24±0.86)μg/L,t 1/2 β=(5.60±0.72)h,T max =(1.71±0.26)h,AUC 0～24 = (59.56 ±9.84) μg·h/L ,without significant difference between the active and control groups. The relative bioavailability obtained was (101.68±12.35)%. Conclusion:The pharmacokinetic profile for the 2 tablets was sim ilar so it may be concluded that they are bioequivalent.