Relative Bioavailability and Bioequivalence of Valaciclovir Hydrochloride Tablets in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of two kinds of preparations of valaciclovir hydrochloride.METHODS:This was a randomized two-way cross-over study.A total of 18 healthy volunteers were randomly assigned to receive single oral dose of test valaciclovir tablets(trial group) or reference valaciclovir tablets(control group),with the plasma aciclovir concentrations determined by HPLC,the pharmacokinetics parameters calculated and the relative bioavailability evaluated using 3p97 program.RESULTS:The main pharmacokinetic parameters test and reference valaciclovir hydrochloride tablets were as followsAUC0～ 24(12.85? 4.32) vs.(12.19? 4.63) ?g? h? mL-1;AUC0～ ∞(14.65? 5.75) vs.(13.27? 5.03) ?g? h? mL-1;Cmax(3.55? 0.92) vs.(3.71? 0.97) ?g? mL-1;tmax(1.44? 0.43) h vs.(1.33? 0.37) h;t1/2(6.23? 2.81) h and(4.55? 1.84) h.The relative bioavailability of the test valaciclovir tablets were(111.01? 23.52) %.CONCLUSION:The reference valaciclovir tablets and the test valaciclovir tablets were bioequivalent.