Abstract:
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.
