The bioequivalence study of domestic and imported gliclazide sustained release tablets

Objective To compare the bio-availability between test gliclazide sustained release tablet and commercially available reference tablet.Methods A HPLC/MS method was developed and used to determine gliclazide plasma concentrations of 20 healthy volunteers in an open randomized two-way crossover test after single oral dose and multiple oral doses.The pharmacokinetic parameters were estimated.Results After single oral gliclazide sustainde release tablets of reference (30mg) or test (30mg) drugs were given,gliclazide plasma concentration against time was calculated and evaluated.The main pharmacokinetic parameters after a single oral dose of test versus reference drug were as follows: Cmax was 1.21±0.26 vs 1.09±0.24μg/ml,Tmax was 7.4±1.8 vs 7.0±1.6h,AUC0～72 was 26.23±8.65 vs 25.88±8.87μg·h·ml-1,respectively,AUC0~∞ was 27.65±9.80 vs 27.12±9.90μg·h·ml-1. The Cmax,Cmin,Cav,Tmax,DF,AUCss of gliclazide test versus reference tablets after multiple oral doses were 1.37±0.49 vs 1.31±0.41μg/ml;0.069±0.075 vs 0.060±0.066μg/ml;0.41±0.20 vs 0.42± 0.19μg/ml;6.0±1.7 vs 6.6±2.6h;3.46±0.99 vs 3.29±1.06;29.66±14.10 vs 29.95±13.40μg·h ·ml-1 respectively.The AUC and AUCss were tested after natural logarithmic transformation and no difference with statistical significance was found.Conclusions The test formulation is bioequivalent to the reference formulation for gliclazide.