Journal of Bioequivalence & Bioavailability

Juana Isabel Balderas-Acata

Publications

• Research Article
  Bioavailability of Two Coated-Tablet Formulations of a Single Dose of Pantoprazole 40 mg: An Open-Label, Randomized, Two-Period Crossover, Comparison in Healthy Mexican Adult Volunteers
  Author(s): Juana Isabel Balderas-Acata, Esteban Patricio Ríos-Rogríguez Bueno, Sofía del Castillo-García, Clara Espinosa-Martínez, Victoria Burke-Fraga and Mario González-de la ParraJuana Isabel Balderas-Acata, Esteban Patricio Ríos-Rogríguez Bueno, Sofía del Castillo-García, Clara Espinosa-Martínez, Victoria Burke-Fraga and Mario González-de la Parra
  
  Pantoprazole is a proton pump inhibitor indicated for the treatment of acid-related gastrointestinal diseases such as reflux esophagitis, duodenal and gastric ulcers. The aims of this study were to compare the bioavailability and to determine the bioequivalence of a test and reference formulation of oral pantoprazole 40 mg, administered as a coated tablet, and to generate data regarding the oral bioavailability of this drug in the Mexican population. This single-dose, randomized-sequence, open-label, 2-period crossover study was conducted on a total 34 healthy Mexican adult subjects of both genders, with a 7-days washout period. Study formulations were administered after a 10-hour overnight fast. For pharmacokinetic analysis, blood samples were drawn at 0 (baseline), 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2.0, 2.5, 3, 3.5, 4, 5, 6, 8, and 10 hours after administration. Plasma concentrations o.. View More»
  DOI: 10.4172/jbb.1000063

  Abstract PDF