Studies on bioequivalence of orally disintegrating tablets and conventional tablets of cetirizine hydrochloride

Objective To evaluate the bioequivalence of two kinds of orally disintegrating tablets and conventional tablets of cetirizine hydrochloride.Methods Single doses of orally disintegrating tablets and conventional tablets of cetirizine hydrochloride were administered orally in 20 volunteers in an open,randomized,and crossover study of the pharmacokinetics and bioequivalence,and plasma concentrations of cetirizine hydrochloride were determined with HPLC.Results The pharmacokinetic parameters of test and control preparations were as follows: Tmax(0.6±0.27) and(0.9±0.32) h;Cmax(644.5±108.4) and(654.1±102.4) ng·mL-1;t1/2(8.6±2.0) and(8.9±3.6) h;AUC0-t(4 944.3±750.4) and(5 128.9±991.4) ng·h·mL-1;AUC0-∞(5 535.8±941.1) and(5 868.7±1519.7) ng·h·mL-1.The relative bioavailability of test formulation was(98.1±14.9)%.The result of statistical analysis on above parameters showed that there was no significant difference between two preparations.Conclusion The two preparations were bioequivalent.