Juana Isabel Balderas-Acata
Mexico
Research Article
Bioavailability of Two Oral-Suspension Formulations of a Single Dose of Nitazoxanide 500 mg: An Open-Label, Randomized-Sequence, Two-Period Crossover, Comparison in Healthy Fasted Mexican Adult Volunteers
Author(s): Juana Isabel Balderas-Acata, Esteban Patricio Ríos-RogríguezBueno, Fabiola Pérez-Becerril, Clara Espinosa-Martínez, Victoria Burke- Fraga and Mario González-de la ParraJuana Isabel Balderas-Acata, Esteban Patricio Ríos-RogríguezBueno, Fabiola Pérez-Becerril, Clara Espinosa-Martínez, Victoria Burke- Fraga and Mario González-de la Parra
Nitazoxanide is an oral broad-spectrum parasiticidal agent. In Mexico, the oral powder for suspension of nitazoxanide is indicated for the treatment of antiprotozoal and anthelmintic infections in patients of 1 year or older. The aims of this study were to compare the bioavailability and to determine the bioequivalence of a test and reference formulation of oral nitazoxanide 500 mg, administered as a suspension, and to generate data regarding the oral bioavailability of this drug on the Mexican population. This single-dose, randomized-sequence, open-label, 2-period crossover study was conducted on a total of 26 Mexican adult subjects of both genders, with a 1-week washout period. Study formulations were administered after a 10-hour overnight fast. For pharmacokinetic analysis, blood samples were drawn at 0 (baseline), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10 and 12 hours after adm.. View More»
DOI:
10.4172/jbb.1000056