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-Aguirre1*, Mireya Lopez-Gamboa1, Teresita de Jesus Castro-Sandoval1, Roxana Hernández-González1, Julian Mejía-Callejas1, María de los Angeles Melchor-Baltazar1 and Juan Salvador Canales-Gomez2
- *Corresponding Author:
- Jose Antonio Palma-Aguirre
Amores 320, Col . Del Valle
03100 Mexico City, Mexico
E-mail: [email protected]
Received Date: December 17, 2009; Accepted Date: February 04, 2010; Published Date: February 05, 2010
Citation: Palma-Aguirre JA, Mireya LG, de Jesus CST, Hernández- González R, Mejía-Callejas J, 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: 023-027. doi: 10.4172/jbb.1000026
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.
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.