Bioequivalence of gliclazide sustained release tablets

Objective To evaluate the oral bioavailability and bioequivalence of gliclazide sustailued release tablets in healthy volunteers.Methods An HPLC method was used to determine the plasma concentration of gliclazide in healthy volunteers.Gliclazide pharmacokinetic parameters were calculated and evaluated with ANOVA.The bioequivalence ofthe two formulations were evaluated by two one-sidedt-tests.Results The AUC0 ~72,AUC0 ~∞,tmax,Cmaxof gliclaz-ide test and reference tablets in a state of fasting were(43.4 ±6.8) and(43.9 ±11.0) mg.h.L-1,(46.9 ±8.0) and(47.3 ±12.2) mg.h.L-1,(6.8 ±2.8) and(6.4 ±2.0) h,(2.4 ±0.6) and(2.4 ±0.6) mg.L-1,respectively,and the relative bioavailability was(102.0 ± 18.4) %.No significant differences were found a-mong the main pharmacokinetic parameters of the two preparations by ANOVA,and the two one-sided t-tests showedthat the trial preparation and the reference preparation were bioequivalent.The 90 %confidence intervals of AUC0 ~72andCmaxwere within 80 %~125 %and 70 %~143 %,respectively.Conclusion The gliclazide test and reference tab-lets are bioequivalent.