Bioequivalence study of gliclazide sustained release tablets

OBJECTIVE To study the pharmacokinetics and bioequivalence of gliclazide test sustailued release tablets and reference tablets after single oral dose and to evaluate the releasing and fluctuating characteristics after multiple oral doses.METHODS An HPLC method was used to determine gliclazide plasma concentrations of 20 healthy volunteers in an open randomized two way crossover test.gliclazide pharmacokinetic parameters were calculated and evaluated with DAS2.0 program.RESULTS The t1/2,Cmax,tmax,AUC0-72 of gliclazide test and reference tablets after single oral dose were(24.2±2.5)h and(23.8±3.2)h,(1.9± 0.6)mg·L-1 and(2.2±0.5)mg·L-1,(6.9±1.0)h and(6.4±1.0)h,(54.7±14.2)mg·h·L-1 and(58.8±16.4)mg·h·L-1,respectively,and the relative bioavailability was(93.7±8.4)%.The AUCSS,Cmax,Cmin,DF of gliclazide test and reference after multiple oral doses were(59.7± 24.4)mg·h·L-1 and(62.6±25.5)mg·h·L-1,(3.4±1.3)mg·L-1 and(3.8±1.4)mg·L-1,(1.9±0.8)mg·L-1 and(1.6±0.9)mg·L-1,(61.3±17.9)% and(87.5±21.5)%,respectively,and the bioavailability was(95.9±11.2)%.CONCLUSION The gliclazide sustained release tablets and Diamicron are bioequivalent,and well compared in concern of tmax,AUC0-72,AUC0→∞,AUCSS and DF.