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

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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 | Canales-Gomez Juan Salvador

Journal: Journal of Bioequivalence & Bioavailability
ISSN 0975-0851

Volume: 02;
Issue: 01;
Start page: 018;
Date: 2010;
Original page

Keywords: Citalopram | Pharmacokinetics | Bioequivalence | Bioavailability | Human | HPLC

ABSTRACT
The aim of this study was to compare the bioavailability and determine the bioequivalence of one test formulation (citalopram 20 mg oral tablet) with its corresponding list reference-drug formulation in Mexico. A single dose, randomized, open-label, 2-period crossover, post-marketing study with a 2-weeks washout period between doses was conducted. Blood samples were 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 after dosing. Citalopram plasma levels were determined usingHPLC assay method. A total of 24 subjects were enrolled in the study. The bioequivalence test drug values were Cmax of 26.37 ng/ mL, tmax of 3.76 h, AUC0-t of 613.84 h.ng/mL, AUC0-∞ of 879.65 h. ng/mL, and reference drug values of Cmax of 25.50 ng/mL, tmax of 3.96 h AUC0-t of 596.65 h. ng/mL, AUC0-∞ of 982.38 h. ng/mL. No period or sequence effect was observed. In this study in healthy Mexican adult subjects, a single dose of citalopram 20 mg of the test formulation was found to be bioequivalent to the corresponding reference formulation according to the regulatory definition of bioequivalence based on the rate and extent of absorption. Both formulations were generally well tolerated.
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