Pharmacokinetics of Amoxicillin/Clavulanic Acid Combination After Oral Administration of New Suspensions Formulation in Human Volunteers Publisher



Mostafavi SA^{1, 3} ; Dormiani K² ; Khazaie Y² ; Azmian A² ; Zargarzadeh MR² Show Affiliations
Source: International Journal of Pharmacology Published:2007

Abstract

The pharmacokinetic properties of amoxicillin and clavulanic acid when used alone or in combination may show an interaction between these two agents that might decrease the absolute bioavailability of clavulanic acid. In an open, randomized, replicated Latin square under fasting condition, the pharmacokinetics of new formulations of amoxicillin/ clavulanic acid were compared with reference formulation after single dose administration in 15 healthy male volunteers. Subjects were given equal molar doses of new suspension formulations of amoxicillin/ clavulanic acid or Augmentin® as reference product. After one week wash-out period blood samples were collected exactly before and after drug administration of any formulations at different time points up to 6 h. The concentrations of the antibiotics in plasma were measured by validated high-performance liquid chromatography methods. Three formulations exhibited a similar mean Cmax and Tmax either for amoxicillin or for clavulanic acid. The AUC0inf for amoxicillin was about 1278±172 μg min mL-1 and it was about 354±66 μg min mL-1 for clavulanic acid. There were no significant differences in pharmacokinetic parameters between three formulations. The two generic formulations investigated in this study proved to be bioequivalent with brand-name Augmentin® with regard to the pharmacokenetic parameters Cmax, AUC0t, AUC0inf and tmax. We may conclude that two new formulations are bioequivalent with reference suspension and can be considered equally effective in medicinal practice. Moreover, there were no interaction in pharmacokinetic parameters between amoxicillin and clavulanic acid. No serious adverse event was observed with the studied drugs. © 2007 Asian Network for Scientific Information.