Estudo de bioequivalencia de duas formulações de cefadroxil - capsula (500mg) em voluntarios sadios de ambos os sexos

AUTOR(ES)
DATA DE PUBLICAÇÃO

2005

RESUMO

The objective of this study is to compare the bioequivalence of Cefadroxil- capsule 500 mg formulated by Apotex of Brazil Ltda (test formulation) and Cefamox by LaboratoryBristol-Myers Squibb (reference formulation) in volunteers of both sexes. This study was necessary for the commercialization of medicines. The study was conducted with a randomized two-period crossover design (2x2) and a one-week washout period, the same volunteers received, in each period, a test formulation or a reference formulation. The treatment sequence was determined by a randomization list, automatically produced by Medicines Clinical Trials Control System. Plasma samples were obtained over a 36-hour interval. Cefadroxil concentrations were analyzed by combined high pressure liquid chromatography and UV-visible detection (HPLC-UV). From the Cefadroxil plasma concentration vs time curves the following pharmacokinetic parameters were obtained: AUC IND. 0-t , AUC IND. 0-INFINITO and C IND. max . The Geometric mean of Cefadroxil / Cefamox 500 mg for individual percentage ratio was 105.58% (90% CI=102.17%; 109.10%) for an area under the cefadroxil plasma concentration versus time curves (0-t), 104.74% (90% CI= 101.55%; 108.02%), for an area under the cefadroxil plasma concentration versus time curves ( 0-INFINITO ), and 112.08% (90% CI=105.59%; 118.97%) for maximum observed plasma concentration. Conclusion: Since 90% CI for both C IND. max , AUC IND. 0-t , and AUC IND. 0-INFINITO were within the 80-125% interval proposed by the RDC 135 (ANVISA/may 2003), it was conc1uded that Cefadroxil - capsule 500 mg was bioequivalent to Cefamox, according to both the rate and the extension of absorption

ASSUNTO(S)

farmacocinetica cefalosporinas bioavailability cephalosporin biodisponibilidade bioequivalence

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