Journal of Bioequivalence & Bioavailability

Alejo-Cisneros PL

Publications

• Research Article
  Bioequivalence of Two Prolonged-Release Diclofenac Sodium Formulations in Healthy Volunteers: A Randomized, Crossover, Double-Blind Study
  Author(s): González-Delgado CA, Padrón-Yaquis AS, Jiménez-Rodríguez D, Cazanave-Guarnaluce D, Alejo-Cisneros PL, Festary-Casanovas T, Barrios-Sarmiento M, Díaz-Machado A, Pérez-Rodríguez S, Martín-Trujillo A, Barrero-Viera L and García-García I González-Delgado CA, Padrón-Yaquis AS, Jiménez-Rodríguez D, Cazanave-Guarnaluce D, Alejo-Cisneros PL, Festary-Casanovas T, Barrios-Sarmiento M, Díaz-Machado A, Pérez-Rodríguez S, Martín-Trujillo A, Barrero-Viera L and García-García I
  
  Background: The implementation of generic drug development programs constitutes a basic component of the global health policy. The aim of this work is to determine the existence of bioequivalence between two prolonged release diclofenac sodium formulations in healthy volunteers. Methods: A phase I, randomized, crossover, double-blind clinical trial was conducted where pharmacokinetics in plasma and biological safety of Voltaren Retard® (reference formulation) and a generic prolonged-release Cuban diclofenac sodium formulation were compared. The sampling period was 24 hours, with a washout time of 15 days between each one. All subjects received, orally, a single dose of 100 mg (one tablet) of the corresponding formulation in each period. Results: Thirty-six volunteers, the half women, with a mean age of 33 years.. View More»
  DOI: 10.4172/jbb.1000361

  Abstract PDF