Alejandra Rosete-Reyes
Mexico
Research Article
Bioavailability of Two Oral-Granule Formulations of a Single Dose of 4-Mg
Oral Granules of Montelukast: A Randomized, Two-Period Crossover
Comparison in Healthy Mexican Adult Volunteers
Author(s): Gabriel Mendoza-Tamayo, Alejandra Rosete-Reyes, Jessica González-Bañuelos, Ericka López-Bojórquez, Victoria Burke-Fraga and Mario González-de la ParraGabriel Mendoza-Tamayo, Alejandra Rosete-Reyes, Jessica González-Bañuelos, Ericka López-Bojórquez, Victoria Burke-Fraga and Mario González-de la Parra
Montelukast is a leukotriene receptor antagonist. In Mexico, the oral granules at the dose of 4 mg are indicated for children aged 6 months to 5 years for the treatment of asthma and/or allergic rhinitis. The aim of this study was to compare the bioavailability and to determine the bioequivalence of a test formulation (oral granules) containing 4 mg of montelukast, with its corresponding reference drug formulation, and to generate data regarding the oral bioavailability of this drug in the Mexican population. This single-dose, randomized-sequence, single-blind, twoperiod crossover study under fasting conditions was conducted on a total of 26 healthy Mexican adult subjects of both genders , with a seven-day washout period. Study formulations were administered after a 10-hour overnight fast. For pharmacokinetic analysis, blood samples were drawn at 0 (baseline), 0.25, 0.5, 1, 1.5, 2, 2... View More»
DOI:
10.4172/jbb.1000253