Research Article
Bioequivalence of Two Oral Tablet Formulations of Betahistine 24 Mg: Single-Dose, Open-Label, Randomized, Two-Period Crossover Comparison
in Healthy Individuals
Author(s): Larisa Estrada- Marín, Beatriz Cedillo- Carvallo, Augusto Herrera- Coca, Gabriela Bravo- Barragán, Olga Guzmán García and Alejandro Ruiz- ArgüellesLarisa Estrada- Marín, Beatriz Cedillo- Carvallo, Augusto Herrera- Coca, Gabriela Bravo- Barragán, Olga Guzmán García and Alejandro Ruiz- Argüelles
A bioequivalence study of betahisitine tablets was conducted. Thirty two healthy Mexican mestizo volunteers received each test (T) and reference (R) formulations of betahistine at a dose of 24 mg in a 2 × 2 cross-over study. There was a three-day washout period between the two formulations. Plasma concentrations of betahistine were monitored by an ultra-performance liquid chromatography coupled to tandem mass spectrometry (UPLC/MS/MS) for over a period of 24 h after the administration. AUC0-t (the area under the plasma concentration–time curve from time 0 to last sampling time) and AUC 0-∞ (that from time 0 to infinity) were calculated by the linear-log trapezoidal rule method. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration–time data. Analysis of variance was carried out using logarithmically tr.. View More»
DOI:
10.4172/jbb.1000207