Pereda-Girón Mariel
Mexico
Research Article
Bioavailability of Two Oral Tablet Formulations of citalopram 20 mg: Single-Dose, Open-Label, Randomized, Two-Period Crossover Comparison in Healthy Mexican Adult Subjects
Author(s): Jose Antonio Palma- Aguirre, Lopez-Gamboa Mireya, Castro-Sandoval Teresita de Jesus, Pereda-Girón Mariel, Zamora-Bello Elisa, Melchor-Baltazar María de los Angeles, Mendez Carmona Ma Esther and Canales-Gomez Juan SalvadorJose Antonio Palma- Aguirre, Lopez-Gamboa Mireya, Castro-Sandoval Teresita de Jesus, Pereda-Girón Mariel, Zamora-Bello Elisa, Melchor-Baltazar María de los Angeles, Mendez Carmona Ma Esther and Canales-Gomez Juan Salvador
The aim of this study was to compare the bioavailab ility and determine the bioequivalence of one test formul ation (citalopram 20 mg oral tablet) with its correspondi ng list reference-drug formulation in Mexico. A single dose, randomized, open-label, 2-period cro ss- over, post-marketing study with a 2-weeks washout p e- riod between doses was conducted. Blood samples wer e drawn at baseline, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6. 0, 7.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 y 120.0 hours af ter dos- ing. Citalopram plasma levels were determined using HPLC assay method. A total of 24 subjects were enrolled in the study. The bioequivalence test drug values were C max of 26.37 ng/ mL, t max of 3.76 h, AUC 0-t of 613.84 h.ng/mL, AUC 0- ∞ of 879.65 h. ng/mL, and reference drug values of C max of 25.50 ng/mL, t max of 3.96 h AUC 0-t of 596.65 h. ng/mL, AUC 0- ∞ of 982.38 h. ng/m.. View More»
DOI:
10.4172/jbb.1000025