Estudo de bioequivalencia de duas formulações de diclofenaco de potassio usando a cromatografia liquida de alta pressão acoplada ao espectrometro de massa (LC-MS-MS)
AUTOR(ES)
Moises Luis Pirasol Vanunci
DATA DE PUBLICAÇÃO
2003
RESUMO
The aim of this study was to evaluate, on human volunteers, the performance of Potassium Diclofenac tablet formulation (Clofenak coated tablets 50 mg, by Medley S/A Indústria Farmacêutica) as opposed to standard Potassium Diclofenac dragee formulation (Cataflam dragees 50 mg, by Novartis Biociências S/A., Brazil). Twenty-four healthy volunteers, as assessed by clinical and laboratory test evaluations, were enrolled in the study. The study was a single dose, two-way randomized crossover design comparing Potassium Diclofenac tablet formulation (Clofenak coated tablets 50 mg, by Medley S/A Indústria Farmacêutica) to standard Potassium Diclofenac dragee formulation (Cataflam dragees 50 mg, by Novartis Biociências S/A., Brazil). Plasma samples for determination of Diclofenac were obtained during pre-dose in frequent intervals up to 12h afier dosing. Total Diclofenac plasma concentrations were quantified by a validated method mploying high-performance liquid chromatography coupled to mass spectrometry (LC-MS-MS)
ASSUNTO(S)
medicamentos genericos - farmacocinetica diclofenaco
ACESSO AO ARTIGO
http://libdigi.unicamp.br/document/?code=vtls000304393Documentos Relacionados
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