Pharmacokinetics and Bioequivalence of Gliclazide Sustained-release Tablets in Healthy Volunteers after High Fat Diet

The pharmacokinetics and bioequivalence of gliclazide sustained-release tablets in healthy volunteers after high fat diet were discussed.The domestic and imported tablets were used as test and reference preparation. According a randomized two-period crossover design,a single oral dose of 60 mg gliclazide sustained-release tablets was given to 18 healthy volunteers after high fat diet.The plasma concentrations of gliclazide were determined by HPLC-UV, with glipizide as the internal standard.The main pharmacokinetic parameters for test and reference preparation were as follows:C_(max)(2.457±0.376)and(2.443±0.310)mg/L,AUC_(0-t)(40.782±7.653)and(39.341+5.389)mg·h·L~(-1), AUC_(0-∞)(42.456±7.029)and(42.913±8.154)mg·h·L~(-1),t_(max)(5.39+0.85)and(5.50±0.71)h,respectively.The relative bioavailability of the test preparation was(103.3±8.4)%.The results showed that the test and reference preparation were bioequivalent.