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Frias Iniesta, Jesus AAutor o CoautorGuerra Lopez, Pedro EnriqueAutor o CoautorCarcas, AjAutor o Coautor

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Comparative bioavailability of two oral 875/125mg sachet formulations of amoxicillin/clavulanic acid in healthy volunteers

Publicado en:CLINICAL DRUG INVESTIGATION. 18 (3): 217-224 - 1999-10-08 18(3), DOI: 10.2165/00044011-199918030-00006

Autores: Galvez-Mugica, MA; Frias-Iniesta, J; Guerra, P; Carcas, AJ; Fernandez-Aijon, A; Montuenga, C; Gomez-Barrios, E

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Objectives and Design: The aim of this single-dose, randomised, two-sequence, crossover study in 24 healthy volunteers was to establish the bioequivalence of two different sachet formulations of amoxicillin/clavulanic acid 875/125mg (Augmentine(R) and Duonasa(R)). Patients and Methods: Twenty-four healthy volunteers aged 18 to 30 years fasted from 10 hours before until 2.5 hours after administration of each sachet. Venous blood samples were taken prior to each administration and at 14 different times within 24 hours after the dose, and plasma concentrations of amoxicillin and clavulanic acid were determined by high performance liquid chromatography. Clinical adverse events were recorded after an open question and a symptoms checklist during the study. Main Outcome Measures: For the purpose of bioequivalence analysis, area under the curve (AUC) and peak plasma concentration (C-max) were considered to be primary variables and time to C-max (t(max)) a secondary one. C-max and t(max) were obtained directly from plasma data, the elimination rate constant (k(el)) was estimated by log-linear regression, and AUC was calculated by the trapezoidal rule. AUC and C-max were tested for bioequivalence after log-transformation of data. Results: The 90% standard confidence intervals (CI) of the mean AUC values for the test/reference ratios were 1.01 to 1.18 for amoxicillin and 0.87 to 1.06 for clavulanic acid. There was no significant difference in the bioavailability of either product judged from Cmax ratios for amoxicillin (90% CI 1.01 to 1.16) and clavulanic acid (90% CI 0.90 to 1.12). These results were within the bioequivalence acceptable range of 90% CI 0.80 to 1.25. Overall, disposition parameters for these formulations were roughly proportional to those found in the literature after single-dose administration of other formulations with different strengths and amoxicillin/clavulanic acid ratios. Importantly, interindividual variability values were consistent with these previously reported. Conclusions: The two formulations were found to be bioequivalent and, therefore, interchangeable.

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