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Bioequivalence study of two oral formulations of clarithromycin in human male subjects.

Author(s): Khan MK, Khan MF, Mustafa G, Sualah M

Affiliation(s): Faculty of Pharmacy, Gomal university, Dera ismail, Khan, Pakistan. khalidryu57@hotmail.com

Publication date & source: 2011-01, Pak J Pharm Sci., 24(1):43-6.

Publication type: Comparative Study; Randomized Controlled Trial

To assess the bioequivalence of tablets formulations of Clarithromycin 500 mg 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.

Page last updated: 2011-12-09

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