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Revista chilena de infectología

versión impresa ISSN 0716-1018

Resumen

GAETE G, LEONARDO et al. Bioequivalence evaluation of two brands of clarithromycin suspension available in the Chilean pharmacopeia. Rev. chil. infectol. [online]. 2003, vol.20, n.3, pp.178-183. ISSN 0716-1018.  http://dx.doi.org/10.4067/S0716-10182003000300005.

A comparative bioavailability study was conducted in order to test the bioequivalence between two formulations of clarithromycin in suspension 250 mg/5 mL, a local formulation (Pre-ClarÒ), and the original product (KlaricidÒ). In both cases, a single oral dose of 500 mg was used. A microbiological assay was used to determine the antibiotic plasmatic concentrations. The assay is based on the correlation between the inhibition of bacterial growth in agar plates and the plasmatic concentration of clarithromycin. A total of twelve healthy young volunteers participated and completed the study protocol, which was approved by the local ethic committee. None of the pharmacokinetic parameters such as peak plamatic level (Cmáx), half-live (t1/2), area under the curve of plasmatic levels vs time, from 0 to inifinity (ABC0-¥) and velocity rate constant (Kabs), showed significant differences for both products. According to the guidelines recommended by the FDA and by means of our findings, we can assure that Pre-Clar® and Klaricid® in suspension are bioequivalents. Therefore, we may assume that both products are interchangeable without compromising clinical efficacy.

Palabras clave : Clarithromycin; Suspension; Bioequivalence; Pharmacokinetics.

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