Bioequivalence of amoxicillin and clavulance potassium (14∶1) chewing tablets and dispersing tablet in healthy volunteers

Objective To study the bioequivalence of amoxicillin -clavulante potassium(14∶1) in chewing tablet、disperse tablet and reference tablet. Methods In a randomized three cycles study(5 days in distance), a single oral dose of a chewing tablet or a dispersing tablet or a common form tablet (each tablet contains amoxicillin 600 mg and clavulante potassium 42.9 mg) was given to every volunteer in each experiment. Samples at difference time were obtained and drug concentration were measured by bioassay method. Results The pharmacokinetic parameters of chewing tablet, disperse tablet and common form granules were calculated as following: amoxicillin: AUC (0-8h) were (22.48±4.5),(22.16±3.79) and (22.51±4.31) mg·h·L~(-1), C (max) were (9.079±1.86), (8.822±1.84) and (8.6892±1.13) mg·L~(-1), respectively. Clavulante potassium: AUC (0-8h) were (22.48±4.5),(22.16±3.79) and (22.51±4.31) mg·h·L~(-1), and C (max) were (0.553±0.260) ,(0.613±0.241) and (0.602±0.206) mg·L~(-1). Conclusion The results demonstrated that three formulation of amoxicillin and clavulante potassium were bioequivalence.