Bioavailability of Gliclazide Sustained Release Tablet in Healthy Volunteers

Abstract Aim This study was to compare bioavailability of two gliclazide sustained release tablets in 18 healthy male volunteers and to evaluate the bioequivalence between the test and the reference tablets. Methods The study was conducted in the crossover, random, two-treatment, two-period design. RE-HPLC method with UV-detection was used to determine the plasma drug concentration. Results The pharmacokinetic parameters obtained after single-dose oral administration of the two gliclazide sustained release tablets showed that there were not significant difference between AUC, Cmax, Tpeak, MRT. The relative bioavailability of the test tablet (TT) was 102.4%. The result of the study on the multiple-dose indicated the Tpeak, Cmax, AUC0-48h, Cmin, AUCss and DF of TT and reference tablet (RT) were similar, however the Cav of TT is higher than that of RT. The relative bioavailability of TT was 101.2%. Conclusion The new sustained release tablet was bioequivalent to RT, it has good sustained release property. Key words gliclazide; bioavailability; sustained releas