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

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.