Relative bioavailability of clavulanic acid/amoxicillin dispersive tablets in healthy volunteers / 中国药理学通报

ABSTRACT

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 Tmax (0.89± 0.25) h and (1.01±0.30) h; Cmax (1.92±0.64) mg·L-1 and (1.49±0.65) mg·L-1; AUC0→∞ (4.347±1.542) mg·h·L-1 and (3.395±1.468) mg·h·L-1, the pharmacokinetic parameters for amoxycillin were Tmax (1.15±0.41) h and (1.34±0.40) h; Cmax (5.81±1.40) mg·L-1 and (4.60±1.37) mg·L-1; AUC0→∞ (13.472±3.114) mg·h·L-1 and (11.937±2.735) mg·h·L-1. The clavulanic acid Tmax of clavulanic acid/amoxicillin dispersive tablet was significantly shorter, clavulanic acid and amoxicillin Cmax, AUC0→∞ of clavulanic acid/amoxicillin dispersive tablet were significantly greater than the control Anqi tablet respectively, while there was no significant difference between amoxicillin Tmax of two tablets. CONCLUSION: The bioavailability of clavulanic acid/amoxicillin dispersive tablet is superior to Anqi tablet.