The objective of this study was to confirm if two formulations of amoxicillin and clavulanic
acid (suspension) are bioequivalent.
Test product was AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; Glaxo
Wellcome France) and reference product AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic
acid/ 5 ml; GlaxoSmithKline Mexico). The single dosage was 10 ml of suspension.
The study was prospective, open-label, randomized, crossover, single dose, with 02
treatments, 02 sequences and 02 periods, under fasting conditions.
The population was composed of 35 healthy volunteers, both genders, adults between 18-50
years.
The comparative bioavailability of the two formulations was evaluated based in statistical
comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
in blood.