Estudos de farmacocinetica comparada de drogas (bioequivalencia), aplicação de tres diferentes metodologias na determinação de niveis circulantes de farmacos

AUTOR(ES)
DATA DE PUBLICAÇÃO

1998

RESUMO

The aim of this thesis was to perform three different studies on clinical pharmacology (clinical assays). The determination of pharmacokinetic values were used in order to compare two formulations (each assay) of the same drug, from different sources. We used AUC[0-12(24) or (48)h], tmax and Cmax to refer if the drugs are bioequivalent or not. Ali the clinical protocols were approved by the Ethic$ Committee of the UNICAMP University Hospital and ali the subjects gave written informed consent. Three groups of healthy, male volunteers were used in order to obtain the information. Each group was composed for two sub-groups for the respective study. The drugs studied were: 1- cyclosporine oral solution (ciclospor from Biosintética versus sandimmun fron Sandoz) 5mg/kg; 2- lincomycin capsules (lincomicina from Abbott versus lincocin from Upjohn) 500mg, and 3- ambroxol capsule - slow release (ambril from Merck versus ambroxol from Euderma SPA) 75mg. The studies were conducted in an open randomized two period crossover fashion with fourteen .days washout period between doses. During each period, the volunteers were hospitalized at 8:00 p.m. having already had a norm_1 evening meal, and after an overnight fast they received at 7:00 a.m. a single dose equivalent to the correct study and according to the appropriated randomization code. After the capsule administration the volunteers were asked to drink 200ml of tap water. Blood samples were taken from suitable forearm vein before and at different intervals until 12h for lincomycin; 24h for cyclosporine and 48h for ambroxol. Each sample was treated according the specific methodology. Radioimmunoassay (RIA) was the method choused for the cyclosporine whole blood determination

ASSUNTO(S)

farmacocinetica medicamentos

ACESSO AO ARTIGO

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