Bioequivalence of amoxicillin and clavulanic acid tablets in healthy volunteers

Objective:To study the relative bioequivalence of domestic and imported amoxicillin and clavulanic acid tablets.Methods:The randomized and crossover study was conducted in 10 healthy male volunteers.After a single dose of the drugs their plasma drug concentration was determined by microbiological assay.Results:Both the domestic and imported tablets of amoxicillin and clavulanic acid fitted to one compartment model.The pharmacokinetics parameters obtained were:C max =(5.17± 0.45 )mg/L,T max =(1.05±0.16)h,t 1/2 =(1.16±0.17)h,AUC 0～t =(12.89±1.03)(mg·h)/L for domestic amoxicillin;C max =(5.25±0.46)mg/L,T max =(1.08±0.23)h,t 1/2 =(1.37±0.23)h,AUC 0～t =(13.54±0.59)(mg·h)/L for imported amoxicillin;C max =(3.94±0.52)mg/L,T max = (1.10± 0.21)h,t 1/2 =(0.98±0.11)h,AUC 0～t =(8.25±0.92)(mg·h)/L for domestic clavulanic acid;C max =(4.10±0.35)mg/L,T max =(1.03±0.10)h,t 1/2 =(1.01±0.14)h,AUC 0～t =(8.18± 0.51) (mg·h)/L for imported clavulanic acid.The relative bioequivalence was:(95.3±7.3)% for amoxicillin;(100.6±6.0)% for clavulanic acid.Conclusion:The domestic and imported amoxicillin and clavulanic acid tablets are bioequivalence.