Original Articles
Abdalwali A. Saif, Maged Alwan
Abstract
Manufacturing Co., Yemen) as the test and Augmentin® (GlaxoSmi thKl ine, UK) as the reference product was carried out in 24 healthy male & female volunteers following a single dose, two-treatment cross-over design. Both test and reference tablets were administered to each subject after an overnight fasting on two treatment days separated by an one-week washout period. After dosing, serial blood samples were collected for a period of 8 h. Serum harvested from blood was analyzed for Co-amoxiclav by a sensitive, reproducible and accurate high pressure liquid chromatography (HPLC) me t h o d . Various pharmacokinetic parameters AUC0-t, AUC0-∞ , Cmax, Tmax, T1/2 and Kel were determined from Serum concentrations of both formulations and found to be in good agreement with reported values. AUC0-t, AUC0-∞ and Cmax were tested for bioequivalence after logtransformation of data. No significant difference was found based on an analysis of variance (ANOVA); 90% confidence interval for test/reference ratio of these parameters was found within bioequivalence acceptance range of 80 – 125%. Based on these statistical inferences, it was concluded that Clavimox® is bioequivalent to Augmentin®. Both products were well tolerated.