Bioequivalence of Amoxicillin and Clavulante Potassium Dispersible Tablet in Healthy Volunteers

Aim To study the bioaequivalemv of amoxicillin and clavulante potassium dispersible tablet.Methods In randomized crossover design,single doses of compound amoxicillin tested tablet or reference tablet 625mg (amoxicillin 500mg,clavulante potassium 125mg) were given to 18 healthy male volunteers.Plasma concentration was measured by bioassay.Results The pharmacokinetic parameters of tested and reference products were calculated as the follows: amoxicillin T max 1.056±0.273 and 1.241±0.396h,C max 5.369±1.124 and 5.213±0.903μg·ml -1 ,AUC 0-6 10.369±1.776 and 10.362±1.370μg·h·ml -1 ,T 1/2ke 1.083±0.166 and 1.101±0.212h,clavulante potassium T max 1.084±0.292 and 1.287±0.284h,C max 2.796±0.878 and 2.742±0.892μg·ml -1 ,AUC 0-6 6.618±2.159 and 6.793±2.274μg·h·ml -1 ,T 1/2ke 1.207±0.165 and 1.261±0.201h,respectively.Conclusion The results demonstrated that two formulation of amoxicillin and clavulante potassium are bioequivalent by statistic analysis results.