Journal of Bioequivalence & Bioavailability

Roberto Bernardo-Escudero

Publications

• Research Article
  Bioequivalence Study of Norfloxacin Tablets (Oranor® and Noroxin®) in Healthy Male Volunteers. A Single Dose, Randomized, Open-label, 2 x 2 Cross-over, in Fasting Conditions Study
  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
  
  Background: Norfloxacin is a fluoroquinolone antibacterial agent suitable for oral administration. This study evaluates if the fasting bioavailability of two solid formulations of 400 mg of norfloxacin is equivalent for obtaining marketing approval from the Mexican regulatory agency. Objective: Establish and compare the comparable bioavailability of 400 mg norfloxacin coated tablets (Oranor) and 400 mg norfloxacin tablets (Noroxin) after administration of an oral dose, in fasting conditions, in healthy male subjects. Subjects and methods: This was a 2 x 2 cross-over, randomized, single-dose, open-label study which included 26 healthy male subjects under fasting conditions. In each of the two study periods (separated by a washout of 7 days) a single dose of test or reference drug was administered. Blood samples were taken up to 24 h post dose, the plasma was separated a.. View More»
  DOI: 10.4172/jbb.1000089

  Abstract PDF