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

Antioxidant level in normal and dialyzed patients using frap method

To examine the serum antioxidant levels like vit-C, vit-E and glutathione in patients with renal diseases who were subjected to dialysis and to evaluate the antioxidant by FRAP method. To find out the involvement of free radicals in pathogenesis of renal disease. Fifty patients with high levels of creatinine and urea level were included in the study of dialysis. A difference of antioxidant level of vit-C, vit-E and glutathione was observed. The study therefore suggests the importance of assessing these marker oxidative stress antioxidant capacities in renal disease during dialysis