Study on the bioequivalence of gliclazide sustained released tablet in healthy volunteers

Aim To evaluate the bioequivalence of two preparations of gliclazide in healthy volunteers.Methods The concentration of gliclazide was measured by high performance liquid chromatography(HPLC) after a single or multiple dosage of gliclazide sustained released tablet in healthy volunteers.The pharmacokinetic parameters of the two preparations were calculated by 3P97 program.LnAUC0~∞,lnAUC0~72 and lnAUC0~τ were used to evaluate the bioequivalence of the two preparations with analysis of variance and two one-side t-test.Results Both the gliclazide extended action tablet were best fitted to one-compartment model.The main parameters of the tested and reference gliclazide after a single dose were as follows:Cmax(2.07±0.61) and(2.26±0.61)mg·L-1;Tmax(5.10±0.55)h and(5.05±0.51)h;T12Ka(1.50±0.26)h and(1.52±0.27)h;T12Ke(8.89±1.56)h and(8.68±1.72)h;MRT(22.63±1.01)h and(22.38±0.93)h;AUC0~72(39.19±8.03)mg·h-1·L-1 and(39.26±8.37)mg·h-1·L-1;AUC0~∞:(45.80±9.51)mg·h-1·L-1 and(45.57±9.76)mg·h-1·L-1;F0~72 and F0~∞(100.19±6.22)% and(100.85±5.88)%,respectively.The main parameters of the tested and reference gliclazide after multiple dose were as follows:Cmax(4.83±0.86)mg·L-1 and(4.69±0.64)mg·L-1;Cmin(0.68±0.14) mg·L-1 and(0.66±0.12)mg·L-1;Tmax:(4.10±0.45) h and(4.10±0.55)h;T12Ka:(2.03±0.53)h and(2.04±0.40)h;T12Ke:(7.24±0.87)h and(7.09±1.14)h;MRT(9.17±0.30)h and(9.19±0.37)h;AUCSS:(41.62±6.48) mg·h-1·L-1 and(42.18±6.03)mg·h-1·L-1;Cav:(1.73±0.27)mg·L-1 and(1.76±0.25)mg·L-1;DF(240.85%±34.07)and(230.23%±24.80%) respectively.The relative bioavailability was(98.60±4.60)%.The AUC0~T,AUC0~∞ or AUCSS,Cmax and Tmax were bioequivalent between the two preparations.Conclusion The tested and reference gliclazide sustained released tablet are bioequivalent.