Original Articles
Sabati A. M. A, Abdalwali A. S
Abstract
A bioequivalence study of two oral formulations of Cefuroxime Axetil 500 mg Bioxime ® (Pharmacare International Manufacturing Co., Yemen) as the test and Zinnat ® (GlaxoSmithKline, UK) as the reference product was carried out in 26 healthy male & female volunteers (one drop out) following a single dose, two sequence, two period, 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 Cefuroxime by a sensitive, selective, 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-∞, Cmax were tested for bioequivalence after log-transformation of data. No significant difference was found based on 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 Bioxime® is bioequivalence to Zinnat®. Both products were well tolerated