Journal of Bioequivalence & Bioavailability

Maligne GE

Publications

• Research Article
  Bioequivalence of Two Oral Dimethyl Fumarate Extended Release Capsules in Healthy Subjects: A Randomized, Open Label, Single-Dose, 2-Way Crossover Study
  Author(s): Maligne GE, Feleder EC, Yerino GA, Otero AM and Roldán EJAMaligne GE, Feleder EC, Yerino GA, Otero AM and Roldán EJA
  
  The hypothesis for the design of this project was that the extended release formulation containing dimethyl fumarate 240 mg DIMEFUL®, developed by Gador will present similar bioavailability with respect to the reference formulation, TECFIDERA® by Biogen Idec, measured in terms of speed and absorption. A clinical study of single-dose bioequivalence (in 2 stages) was designed to be carried out in healthy subjects. This study was opened of two periods, two sequences, crossed, randomized under fasting conditions. Eight out of ten subjects involved in this pilot study (stage 1) were randomized and completed the 2 periods of administration of the treatments. Data of all the subjects who completed the 2 periods of treatment administration were used for pharmacokinetic purposes. The design of the study was adequate to determine the bioequivalence of the Test and Reference Products. Th.. View More»
  DOI: 10.4172/0975-0851.1000380

  Abstract PDF