Bioequiavailability of Simvastatin Orally Disintegrating Tablets in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To compare the bioequiavailability of two simvastatin preparations in human bodies.METHODS:A total of 18 healthy male volunteers were enrolled in a randomized crossover study in which the subjects were randomly assigned to receive single dose of 40mg simvastatin orally disintegrating tablet(test) or simvastatin tablets(reference).The plasma concentrations of simvastatin were determined by LC-MS,and the pharmacokinetic parameters and bioavailability were calculated with 3p97 program.RESULTS:The pharmacokinetics of simvastatin test and reference preparations were fitted the one-compartment model.The main pharmacokinetic parameters of the two preparations were as followingCmax(6.73?5.22) vs.(7.08?5.41)ng?mL-1、tmax(2.11?0.74)vs.(1.89?0.85)h,AUC0～12(19.83?19.09)vs.(19.98?18.20)ng?h?mL-1,AUC0～∞(22.18?20.09)vs.(22.41?21.07)ng?h?mL-1.The relative bioavailability of simvastatin orally disintegrating tabl-et as against simvastain tablet(reference) was (99.25?13.11)%.CONCLUSION:Simvastatin test and reference preparations were bioequivalent.