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)
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

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