Bioequivalence of Amoxicillin Sodium and Clavutante Potassium Capsules in Chinese Healthy Volunteers

OBJECTIVE To evaluate the bioequivalence of Amoxicillin sodium and Clavutante Potassium capsules in Chinese healthy volunteers.METHODS Concentrations of Amoxicillin sodium and Clavutante Potassium in plasma were determined by HPLC/MS/MS after healthy volunteers received a single dose of test dispersible capsule and reference capsule in two-treatment,two-period,crossover design.RESULTS The main pharmacokinetic parameters of Amoxicillin sodium and Clavutante Potassium capsules were as follows: AUC0→10(Amoxicillin) were(19.132±4.196) and(19.001±4.076) g·h·mL 1;AUC0→∞(Amoxicillin) were(19.376±4.197) and(19.301±4.086) g·h·mL 1;Cmax(Amoxicillin) were(6.294±1.819) and(6.293±1.973) g·mL 1;Tmax(Amoxicillin) were(2.000±0.585) and(2.100±0.447)h;AUC0→10(Clavutante) were(4.333±2.317) and(4.275±2.231) g·h·mL 1;AUC0→∞(Clavutante) were(4.383±2.320) and(4.320±2.236) g·h·mL 1;Cmax(Clavutante) were(1.722±0.961) and(1.623±0.813) g·mL 1;Tmax(Clavutante) were(1.850±0.651) and(1.950±0.647)h;The relative bioavailability of Amoxicillin sodium and Clavutante Potassium were(101.8±14.8)% and(112.5±62.0)%.CONCLUSION The results of statistic analysis show that two capsules of Amoxicillin sodium and Clavutante Potassium were bioequivalent.