Journal de bioéquivalence et de biodisponibilité

Abstrait

Bioavailability of Two Oral Tablet Formulations of citalopram 20 mg: Single-Dose, Open-Label, Randomized, Two-Period Crossover Comparison in Healthy Mexican Adult Subjects

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 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/mL. No period or sequence effect w as observed. In this study in healthy Mexican adult subjects, a single dose of citalopram 20 mg of the test formulation wa s found to be bioequivalent to the corresponding reference formu- lation according to the regulatory definition of bioequivalence based on the rate and extent of abso rp- tion. Both formulations were generally well tolerat ed.