title: [Relative bioavailability study of two oral formulations of mycophenolate mofetil in healthy volunteers].
abstract: BACKGROUND
  The bioequivalence of different formulations of a same pharmaceutical product must be tested empirically.
  
  
  OBJECTIVE
  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.
  
  
  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.
authors: Laboratorio de Farmacocinética y Biodisponibilidad de Medicamentos, Centro IFT, Facultad de Medicina, Universidad de Chile, Santiago, Chile. saavedr@med.uchile.cl
authors: Iván
authors: I
authors: Saavedra S
authors: Jaime
authors: J
authors: Sasso A
authors: Luis
authors: L
authors: Quiñones S
authors: Mónica
authors: M
authors: Saavedra B
authors: Leonardo
authors: L
authors: Gaete G
authors: Ignacio
authors: I
authors: Boza T
authors: Cristóbal
authors: C
authors: Carvajal H
authors: Jorge
authors: J
authors: Soto L
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004311:Double-Blind Method; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D008297:Male; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D013810:Therapeutic Equivalency
chemical_list: D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid