Relative bioavailability of clavulanic acid/amoxicillin dispersive tablets in healthy volunteers

AIM To study the relative bioavailability of clavulanic acid/amoxicillin dispersive tablets. METHODS A single oral administration of 125 mg clavulanic acid and 500 mg amoxicillin of dispersive tablet and Anqi tablet to 18 healthy male volunteers in a randomized cross over study. The plasma concentration of clavulanic acid and amoxicillin simultaneous were determined with HPLC. RESULTS The pharmacokinetic parameters of dispersive tablet and Anqi tablet for clavulanic acid were: T max (0 89±0 25) h and (1 01±0 30) h; C max (1 92±0 64) mg·L -1 and (1 49±0 65) mg·L -1 ; AUC 0→∞ (4 347±1 542) mg·h·L -1 and (3 395±1 468) mg·h·L -1 , the pharmacokinetic parameters for amoxycillin were: T max (1 15±0 41) h and (1 34±0 40) h; C max (5 81±1 40) mg·L -1 and (4 60±1 37) mg·L -1 ; AUC 0→∞ (13 472±3 114) mg·h·L -1 and (11 937±2 735) mg·h·L -1 .The clavulanic acid T max of clavulanic acid/amoxicillin dispersive tablet was significantly shorter, clavulanic acid and amoxicillin C max ? AUC 0→∞ of clavulanic acid/amoxicillin dispersive tablet were significantly greater than the control Anqi tablet respectively, while there was no significant difference between amoxicillin T max of two tablets. CONCLUSION The bioavailability of clavulanic acid/amoxicillin dispersive tablet is superior to Anqi tablet.