Estudo de bioequivalencia de duas formulações de comprimidos de fluconazol em voluntarios sadios

AUTOR(ES)
DATA DE PUBLICAÇÃO

1997

RESUMO

The bioequivalence study of two fluconazole tablet formulations: Fluconal (from Laboratório Libbs), and Zoltec (from Laboratório Pfizer) were compared in eighteen healthy male volunteers who received a single dose of 150 mg of each formulation, in an open randomized two period crossover fashion with a fourteen day washout interval between doses. Plasma samples. were obtained over a 48h interval and fluconazol concentrations were determined by HPLC with UV detection. Fromthe plasma fluconazole concentration vs time curves, AUC [O-48h] (area under the concentration vs time curves from O to 48h), Cmax (maximum achieved concentration), T max (time to achieve Cmax) and AUC (area under the concentration vs time curves extrapolated to infinity) were obtained. Ali these variables were analysed using both parametric and non-parametric statistics. Geometric mean Zoltec/Fluconal individual percent ratios were 96.7% (IC 90% 81.7 -114) for AUC[O-48h], 100.7% (IC 90% 85.6 -118), for AUC, 77.4% (IC 90% 66.7 - 133) for Cmax. Although the AUC[0-48] geometric mean ratio (fluconallzoltec) was inside both the FDA (0.8-1.25) and European Community (0.71.43) proposed limits, we cannot affirm that Libbs fluconal is bioequivalent to Pfizer Zoltec according to the extension of absorption, the reason for that being two fold: 1st the calculated area obtained with the [0-48] was less than the 80% of the extrapolated area [0- ] and 2 nd - the number of volunteers was nout enough, since the power obtained for the statistical analysis was 0.52 (Iess than 0.8 as required). This implies in a possible type two error (not detecting a statistical difference due to power weakness)

ASSUNTO(S)

farmacocinetica cromatografia liquida de alta eficiencia

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