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  • About
  • The Global ETD Search service is a free service for researchers to find electronic theses and dissertations. This service is provided by the Networked Digital Library of Theses and Dissertations.
    Our metadata is collected from universities around the world. If you manage a university/consortium/country archive and want to be added, details can be found on the NDLTD website.
1

Perfil FarmacocinÃtico da Talidomida nas Doses de 200mg e 400mg em VoluntÃrios Sadios do Sexo Masculino / PHARMACOKINETIC PROFILE OF THALIDOMIDE IN DOSES 200MG AND 400MG IN HEALTHY MALE VOLUNTEERS

Ana Lourdes Almeida e Silva Leite 26 July 2012 (has links)
nÃo hà / Uma formulaÃÃo de talidomida comprimido 100mg foi avaliada quanto a sua biodisponibilidade (Talidomida, FundaÃÃo Ezequiel Dias - FUNED) em 24 voluntÃrios saudÃveis do sexo masculino. O estudo realizado foi aberto, randomizado, cruzado, com dois tratamentos, dois perÃodos (duas sequÃncias), nos quais os voluntÃrios recebem, em cada perÃodo distinto, 200mg ou 400mg da talidomida com intervalo de sete dias entre os internamentos. O plasma foi obtido de um intervalo de 36 horas. As concentraÃÃes de talidomida foram analisadas por combinaÃÃo de cromatografia lÃquida de alta eficiÃncia (HPLC) acoplada à espectrometria de massas (MS-MS), com ionizaÃÃo em electrospray positivo (MRM). Os dados farmacocinÃticos (mÃdia  desvio padrÃo) obtidos para as formulaÃÃes contendo talidomida de 200mg e 400mg foram 12663,54  2123,99 e 23056,11  3437,08ng*h/mL para AUC0-24, 13282,84  2065,91 e 26292,67  4187,85ng*h/mL para AUC0-∞, 861,58  187,30 e 1131,63  266,93ng/mL para CmÃx, 4,52  1,53 e 6,88  4,71h para TmÃx, 6,89  1,44 e 11,01  4,36 h para t1/2, 0,10  0,02 e 0,07  0,03 1/h para Ke, respectivamente. A comparaÃÃo dos parÃmetros farmacocinÃticos, nas doses de 200 e 400mg, apresentou curvas proporcionais. Quando comparado os parÃmetros farmacocinÃticos deste estudo e os encontrados nos estudos de TEO et al., 1999, NOORMOHAMED et al., 1999 e PAGANOTTO, 2002 foi evidenciado que a formulaÃÃo FUNED apresenta absorÃÃo menor e mais lenta que as demais / formulation of thalidomide 100mg tablet was evaluated for its bioavailability (Thalidomide, FundaÃÃo Ezequiel Dias - FUNED) in 24 healthy male volunteers. The study conducted was open, randomized, with two treatments, and with a two-period crossover design, during which the volunteers were administered 200mg or 400mg of thalidomide with a seven day washout period. Plasma was obtained over a 36h interval. The thalidomide concentrations were analyzed by combined reversed phase liquid chromatography and tandem mass spectrometry (LC-MS-MS) with positive ion electrospray ionization using selected daughter ion monitoring (MRM). The pharmacokinetic data (mean  standard deviation) obtained from the formulations containing thalidomide 200mg and 400mg were 12663.54  23056.11 2123.99 and 3437.08ng * h/mL for AUC0-24, 13282.84  2065.91 and 26292.67  4187.85ng * h/mL for AUC0-∞, 861.58  187.30 and 1131.63  266.93ng/mL for CmÃx, 4.52  1.53 and 6.88  4.71h to TmÃx, 6.89  1.44 and 11.01  4.36h to t1/2, 0.10  0.02 and 0.07  0.03 1/h for Ke, respectively. The comparison between pharmacokinetic parameters, at doses of 200 and 400mg, presented proportional curves. When comparing the pharmacokinetic parameters of this study and those found in studies of TEO et al., 1999, NOORMOHAMED et al., 1999 and PAGANOTTO, 2002 it was observed that the FUNED formulation presents smaller and slower absorption than the others

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