Bioequivalence study of two oral formulations of clarithromycin in human male subjects.
Summary of "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.
Affiliation
Faculty of Pharmacy Gomal university Dera ismail Khan Pakistan.
Journal Details
This article was published in the following journal.
Name: Pakistan journal of pharmaceutical sciences
ISSN: 1011-601X
Pages: 43-6
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21190917
- DOI: http://dx.doi.org/
Medical and Biotech [MESH] Definitions
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A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).
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Books intended for use in the study of specific subjects, containing systematic presentation of the principles and essential knowledge of the subjects.
Andrology
A scientific or medical discipline concerning the study of male reproductive biology, diseases of the male genital organs, and male infertility. Major areas of interest include ENDOCRINOLOGY; SPERMATOGENESIS; semen analysis; FERTILIZATION; CONTRACEPTION; and CRYOPRESERVATION.
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Chromosomes, Human, Y
The human male sex chromosome, being the differential sex chromosome carried by half the male gametes and none of the female gametes in humans.
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