Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos

Background: The bioequivalence of different formulations of a same pharmaceutical product must be tested empirically. Aim: To evaluate the relative bioavailability for an oralformulation of mycophenolate mofetil (MMF) (Linfonex) compared to the reference formulation (Cellcept) to determine the bio...

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Autores principales:	Saavedra S,Iván, Sasso A,Jaime, Quiñones S,Luis, Saavedra B,Mónica, Gaete G,Leonardo, Boza T,Ignacio, Carvajal H,Cristóbal, Soto L,Jorge
Lenguaje:	Spanish / Castilian
Publicado:	Sociedad Médica de Santiago 2011
Materias:	Biological availability Mycophenolate mofetil Therapeutic equivalency
Acceso en línea:	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872011000700011
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spelling	oai:scielo:S0034-988720110007000112011-09-16Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanosSaavedra S,IvánSasso A,JaimeQuiñones S,LuisSaavedra B,MónicaGaete G,LeonardoBoza T,IgnacioCarvajal H,CristóbalSoto L,Jorge Biological availability Mycophenolate mofetil Therapeutic equivalency Background: The bioequivalence of different formulations of a same pharmaceutical product must be tested empirically. Aim: To evaluate the relative bioavailability for an oralformulation of mycophenolate mofetil (MMF) (Linfonex) compared to the reference formulation (Cellcept) to determine the bioequivalence between both formulations. Material and Methods: A randomized, crossover, double-blind trial in 22 healthy male volunteers, who received a single oral dose of 1000 mg of Linfonex and Cellcept with a washout period of 10 days. Plasma levels of the drug were determined by high performance liquid chr ornatography. Plasma concentrations were plotted and maximum concentration, area under the plasma concentration versus time between 0 and 12 hours after administration and área under plasma concentration curve versus time after administration between 0 and infinity, were calculated for both products. Results: The active compound, mycophenolic acid, was similarly absorbed in both formulations. No statistically significant differences were found in calculated pharmacokinetic parameters between both formulations. Conclusions: Linfonex 500 mg is bioequivalent to Cellcept 500 mg.info:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.139 n.7 20112011-07-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872011000700011es10.4067/S0034-98872011000700011
institution	Scielo Chile
collection	Scielo Chile
language	Spanish / Castilian
topic	Biological availability Mycophenolate mofetil Therapeutic equivalency
spellingShingle	Biological availability Mycophenolate mofetil Therapeutic equivalency Saavedra S,Iván Sasso A,Jaime Quiñones S,Luis Saavedra B,Mónica Gaete G,Leonardo Boza T,Ignacio Carvajal H,Cristóbal Soto L,Jorge Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos
description	Background: The bioequivalence of different formulations of a same pharmaceutical product must be tested empirically. Aim: To evaluate the relative bioavailability for an oralformulation of mycophenolate mofetil (MMF) (Linfonex) compared to the reference formulation (Cellcept) to determine the bioequivalence between both formulations. Material and Methods: A randomized, crossover, double-blind trial in 22 healthy male volunteers, who received a single oral dose of 1000 mg of Linfonex and Cellcept with a washout period of 10 days. Plasma levels of the drug were determined by high performance liquid chr ornatography. Plasma concentrations were plotted and maximum concentration, area under the plasma concentration versus time between 0 and 12 hours after administration and área under plasma concentration curve versus time after administration between 0 and infinity, were calculated for both products. Results: The active compound, mycophenolic acid, was similarly absorbed in both formulations. No statistically significant differences were found in calculated pharmacokinetic parameters between both formulations. Conclusions: Linfonex 500 mg is bioequivalent to Cellcept 500 mg.
author	Saavedra S,Iván Sasso A,Jaime Quiñones S,Luis Saavedra B,Mónica Gaete G,Leonardo Boza T,Ignacio Carvajal H,Cristóbal Soto L,Jorge
author_facet	Saavedra S,Iván Sasso A,Jaime Quiñones S,Luis Saavedra B,Mónica Gaete G,Leonardo Boza T,Ignacio Carvajal H,Cristóbal Soto L,Jorge
author_sort	Saavedra S,Iván
title	Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos
title_short	Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos
title_full	Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos
title_fullStr	Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos
title_full_unstemmed	Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos
title_sort	estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos
publisher	Sociedad Médica de Santiago
publishDate	2011
url	http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872011000700011
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Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos

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