Study on Pharmacokinetics and Bioequivalence of Simvastatin Sustained Release Tablets in Beagle Dogs

OBJECTIVE:To study pharmacokinetics and bioequivalence of Simvastatin sustained release tablets in healthy beagle dogs.METHODS:6 beagle dogs were randomized into two groups.They received oral single dose of Simvastatin sustained release tablets 20 mg(test tablet) or Simvastatin tablets for sale(reference tablet).Plasma samples were collected at different time points.Plasma concentration of simvastatin acid was determined by LC-MS/MS and pharmacokinetic parameters were calculated.RESULTS:The pharmacokinetic parameters of reference tablet vs.test tablet were as follows:Cmax:(23.461±6.043) ng·mL-1 vs.(13.942±3.236) ng·mL-1;tmax:(2.158±0.396) h vs.(4.116±1.145 3) h;t1/2:(4.564±0.645) h vs.(8.143±0.679) h;AUC0～24 h:(118.647±31.989) ng·h·mL-1 vs.(129.977±29.853) ng·h·mL-1.CONCLUSIONS:The absorption rate of test tablet is different from that of reference tablet.The two kinds of tablets are not bioequivalent.