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 1*, Lopez-Gamboa Mireya 1, Castro-Sandoval Teresita de Jesus 1,
Pereda-Girón Mariel 1, Zamora-Bello Elisa 1, Melchor-Baltazar María de los Angeles 1, Mendez Carmona Ma Esther 1, Canales-Gomez Juan Salvador 2 |
1Centro de Estudios Científicos y Clínicos Pharma, S.A. de C.V., Mexico City, Mexico |
2Productos Medix, S. A. de C. V. Mexico City, Mexico |
| *Corresponding author: |
Dr. José Antonio Palma-Aguirre, Amores 320,
Col. Del Valle, 03100 Mexico City, Mexico,
E-mail: jpalma@cecycpharma.com |
|
Received December 09, 2009; Accepted January 22, 2010; Published
January 22, 2010 |
Citation: Palma-Aguirre JA, Mireya LG, de Jesus CST, Mariel PG, Elisa ZB, et al.(2010) Bioavailability of Two Oral Tablet Formulations of citalopram 20 mg: Single-Dose, Open-Label, Randomized, Two-Period Crossover Comparison in Healthy Mexican Adult Subjects. J Bioequiv Availab 2: 018-022. doi: 10.4172/jbb.1000025 |
Copyright: © 2010 Palma-Aguirre JA, et al. This is an open-access
article distributed under the terms of the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction
in any medium, provided the original author and source are credited. |
| 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 using
HPLC 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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