Journal of Bioequivalence & Bioavailability

Mondelo N

Publications

• Research Article
  Comparative Bioavailability of Two Oral Perampanel Formulations in Healthy Subjects: A Randomized, Open Label, Single-Dose, 2-Way Crossover Study
  Author(s): Yerino GA, Feleder EC, Otero AM, Diaz L, Sakson M, Mondelo N and Roldán EJA Yerino GA, Feleder EC, Otero AM, Diaz L, Sakson M, Mondelo N and Roldán EJA
  
  Background: Perampanel is a glutamate non-competitive receptor antagonist that is effective as adjunctive treatment for epilepsy. No studies regarding comparative bioavailability between a generic perampanel formulation and the brand-name product have been published in the literature. Therefore, the goal of the present investigation was to compare the bioavailability and to evaluate the bioequivalence between a novel pharmaceutical equivalent 12 mg film-coated tablet formulation and the reference product. Methods: An open label, randomized-sequence, two-period, two-treatment, single-dose, crossover design study in healthy volunteers(n=24) was conducted. The treatment was split out by a 42 days wash-out period. The informed consent was signed by all volunteers. Healthy subjects of both genders, including non-pregnant and nonlactating females .. View More»
  DOI: 10.4172/jbb.1000353

  Abstract PDF