title: Bioequivalence study of two oral formulations of clarithromycin in human male subjects.
abstract: 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.
authors.affiliation: Faculty of Pharmacy, Gomal university, Dera ismail, Khan, Pakistan. khalidryu57@hotmail.com
authors.forename: M Khalid
authors.initials: MK
authors.lastname: Khan
authors.forename: M F
authors.initials: MF
authors.lastname: Khan
authors.forename: G
authors.initials: G
authors.lastname: Mustafa
authors.forename: M
authors.initials: M
authors.lastname: Sualah
mesh_terms: D000284:Administration, Oral; D000900:Anti-Bacterial Agents / Q000737:chemistry / Q000493:pharmacokinetics / Q000494:pharmacology*; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D017291:Clarithromycin / Q000737:chemistry / Q000493:pharmacokinetics / Q000494:pharmacology*; D018592:Cross-Over Studies; D004058:Diffusion; D004311:Double-Blind Method; D006193:Haemophilus influenzae / Q000187:drug effects; D006207:Half-Life; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D013607:Tablets; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D013607:Tablets; D017291:Clarithromycin