Relative bioavailability andbioequivalence evaluation of gliclazide tablets

Aim To compare relative bioavailability and bioequivalence of gliclazide tablets. Methods Ten healthy male volunteers in two groups were given orally gliclazide tested and reference tablets (160 mg) in randomized crossover study. The serum concentration of gliclazide was assayed by HPLC and the bioequivelence of two formulations was evaluated by analysis of two onesided tests. Results Serum concentration-time curves of gliclazide fitted to an one-compartment open model. Tmax were (4.272±0.631) h and (4.031±0.574) h, Cmax were (7.497±0.935)μg·ml-1 and (7.408±1.171) μg·ml-1 and AUC were (104.986±27.523)μg·h·ml-1 and (108.232±22.437) μg·h·ml-1 for tested and reference tablets, respectively.The relative bioavailability of gliclazide tested tablet was 96.679%.Conclusion The tested and reference tablets of gliclazide are of bioequivalence.