BIOEQUIVALENCE STUDY OF TWO ORAL FORMULATIONS OF CLARITHROMYCIN IN HUMAN MALE SUBJECTS

To assess the bioequivalence of tablets formulations of clarithromycin 500mg each of test and reference products. a single post oral dose of each formulation was given to 14 male healthy volunteers. the study was conducted phase 1, open-label, randomized , complete two- way crossover designed with 7 days wash out period. the plasma concentration of clarithromycin was quantified by validated microbiological assay method. the precision of the method was evaluated using calibrated 14-hydroxyclarithromycin concentration was detected semi quantitatively as equivalent of clarithromycin /ml. the peak plasma concentrations of (3.63±0.80 ug/ml) and (3.31±0.35 ug/ml) was attained in about 1.42 hours and 1.49 hours for both test and reference clarithromycin tablets respectively. the mean ± sd values for total area under the curve (auc) were 22.07±4.90 and 20.16±2.35 h.mg/l for both test and reference tablets respectively. this study indicated that the differences in all the bioequivalence parameters for test and reference clarithromycin formulations are statistically non-significant; hence both formulations are considered bioequivalent.