Titre du document / Document title

A comparative clarithromycin bioavailability study: determination of clarithromycin and 14-(R)-hydroxyclarithromycin under fasting and fed conditions

Auteur(s) / Author(s)

BENNINGER P. ; COOPER A. ; MOISAN R. ; PATEL P. ; THIESSEN J. J. ;

Résumé / Abstract

Objective: To report the first comprehensive analysis of clarithromycin (CLA) and 14-(R)-hydroxyclarithromcin (14R) bioequivalence metrics under both fasting and fed conditions when using a validated analytical method. Methods and materials: In separate, single dose bioequivalence studies, fasting (n = 40) and fed (n = 18) non-smoking subjects entered a 2-treatment, 2-period, 2-sequence, crossover trial to assess the comparative bioavailability of a 500 mg generic clarithromycin tablet (IVAX Pharmaceuticals, NJ, USA) relative to the reference product (Biaxin® Filmtab, Abbott Laboratories, IL, USA). The validated assay employed an HPLC coupled to a triple stage quadrupole mass spectrometer. Results: The analytics permitted plasma samples to be measured for both analytes with high precision and a lower limitofquantitation (LLOQ) of 11 ng/ml. In both fasting and fed studies, and for both analytes, the IVAX product met the common mean geometric ratio and 90% confidence limits in order to be declared bioequivalent with Biaxin Filmtab. Furthermore, the intra-subject variabilities for the comparative AUC metrics in both studies and for both analytes were ≤ 21% and ≤ 26% for C^max. Conclusions: The fasting and fed results present definitive evidence that 500 mg IVAX clarithromycin and Biaxin® Filmtab are bioequivalent under both fasting and fed conditions, whether based on CLA or 14R. Furthermore, at a 500 mg dose, clarithromycin is not a highly variable drug.

Revue / Journal Title

International journal of clinical pharmacology and therapeutics   ISSN 0946-1965 

Source / Source

2004, vol. 42, n^o6, pp. 342-349 [8 page(s) (article)]

Langue / Language

Anglais

Editeur / Publisher

Dustri, München, ALLEMAGNE  (1994) (Revue)

Localisation / Location

INIST-CNRS, Cote INIST : 15902, 35400012006061.0070