Bioequivalence of Simvastatin Tablets in Healthy Volunteers

Objective:To evaluate the bioequivalence of two kinds of Simvastatin tablets in healthy male volunteers.Methods:In a randomized crossover design,20 healthy male volunteers were given a single oral dose of 20 mg test or reference Simvastatin tablets.The concentrations of simvastatin in human plasma were determined by a HPLC-MS/MS method.Results:The main pharmacokinetic parameters of the test and reference Simvastatin tablets were as follows:c_(max) were(3.72±1.77) and(4.02±2.30) ng/ml,t_(max) were(1.5±0.8) and(1.3±0.5) h,AUC_(0~12 h) were(12.11±7.33) and(12.21±5.92) ng·h·ml~(-1),AUC_(0~∞) were(15.52 ± 9.79) and(15.48±9.65) ng·h·ml~(-1),and t_(1/2) were(6.5±4.2) and(5.8±4.7) h,respectively.The relative bioavailability of the test tablets was(103.4±32.6)%.There was no significant difference in c_(max),t_(max),AUC_(0~12 h),and AUC_(0~∞) between the two preparations.The 90% confidential interval of c_(max) and AUC were between 70%~143%,and 80%~125% respectively according to those of the reference tablets.Conclusion:The two preparations were bioequivalent.