Pharmacokinetics and bioequivalence of Simvastatin Tablets in healthy volunteers

Objective:To study the pharmacokinetics and bioequivalence of Simvastatin Tablets in Chinese healthy volunteers. Methods:The plasma concentrations of Simvastatin in 20 healthy male volunteers were determined by LC-MS method after being orally administered with single dose of 40 mg Simvastatin Tablets by randomized crossover way;the pharmacokinetic parameters and the relative bioequivalence of the two preparations of Simvastatin were calculated by DAS Ver 2.0 software. Results:The main pharmacokinetic parameters of Simvastatin were as follows:Cmax were(5.58±3.81) and(4.97±2.84) ng/ml;tmax were(1.58±0.49) and(1.93±0.67) h;t1/2 were(5.74±4.55) and(5.75±4.81) h;AUC0-t were(18.40± 11.65) and(19.74±10.53) ng/(h·ml) ;AUC0-∞ were(24.03±18.91) and(26.62±20.05) ng/(h·ml) for the test preparation and the reference preparation,respectively;the 90% confidence interval of AUC0-t,AUC0-∞ and Cmax of the test preparation were 84.2%-99.3%,85.5%-100.8% and 95.9%-121.0%,respectively;the relative bioavailability of Simvastatin was(93.38±18.99) %. Conclusion:The results of the statistic analysis show that the test preparation and the reference preparation of Simvastatin Tablets are bioequivalent.