Estudio de biodisponibilidad relativa entre dos formulaciones orales de micofenolato mofetilo en voluntarios sanos / Relative bioavailability study of two oral formulations of mycophenolate mofetil in healthy volunteers
Rev. méd. Chile
;
139(7): 902-908, jul. 2011. ilus, tab
Artículo
en Español
| LILACS
| ID: lil-603143
ABSTRACT
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.
Texto completo:
Disponible
Índice:
LILACS (Américas)
Asunto principal:
Inmunosupresores
/
Ácido Micofenólico
Tipo de estudio:
Ensayo Clínico Controlado
/
Estudio pronóstico
Límite:
Adulto
/
Humanos
/
Masculino
Idioma:
Español
Revista:
Rev. méd. Chile
Asunto de la revista:
Medicina
Año:
2011
Tipo del documento:
Artículo
País de afiliación:
Chile
Institución/País de afiliación:
Universidad de Chile/CL
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