Journal of Bioequivalence & Bioavailability

Roberto Bernardo-Escudero

Publications

• Research Article
  Bioequivalence Study of Metoclopramide Hydrochloride 10 mg Tablets in Healthy Male Volunteers
  Author(s): Rosalba Alonso-Campero, Roberto Bernardo-Escudero, María Teresa de Jesús Francisco-Doce, Myriam Cortés-Fuentes, Gilberto Castañeda-Hernandez and Mario I. OrtizRosalba Alonso-Campero, Roberto Bernardo-Escudero, María Teresa de Jesús Francisco-Doce, Myriam Cortés-Fuentes, Gilberto Castañeda-Hernandez and Mario I. Ortiz
  
  The aim of this study was to determine if two oral solid formulations of 10 mg of metoclopramide hydrochloride are bioequivalent, after the administration of one dose PO, in fasting conditions, in healthy male subjects. This study used a single dose, randomized, single-blind, controlled, 2 x 2 cross-over, under fasting conditions, design to compare the 2 products. Subjects received one oral dose of the metoclopramide 10 mg tablet on each treatment period, which were separated by a seven-day wash-out period. Plasma concentrations of unaltered metoclopramide were analyzed by High Performance Liquid Chromatography. Pharmacokinetic parameters were obtained. Schüirmann’s unilateral double t test was performed. Null hypotheses indicating bioinequivalence (p > 0.05) were rejected. Bioequivalence was determined if the quotient of the parameters of C max , AUC 0-t and AUC 0-&infi.. View More»
  DOI: 10.4172/jbb.1000090

  Abstract PDF