Abstract
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.
Highlights
Citalopram, 1 - [3 -propyl] - 1- (4 fluorophenyl) - 1,3 - dihydroisobenzofuran - 5 -carbonitrile, is a drug which belongs to the group of specific serotonin reuptake inhibitors
The subjects for the study arrived at the clinical site the day before the beginning of the study and were randomized in a 1:1 ratio using a table of random numbers to receive citalopram test formulation
Plasma was obtained by centrifugation (2000g for 10 minutes at room temperature) and stored frozen at –70°C until analyzed using high-performance liquid chromatography (HPLC)
Summary
Citalopram, 1 - [3 - (dimethylamino)propyl] - 1- (4 fluorophenyl) - 1,3 - dihydroisobenzofuran - 5 -carbonitrile, is a drug which belongs to the group of specific serotonin reuptake inhibitors. It is used alone or in combination with other antidepressive and antipsychotic drugs to help treat a variety of psychiatric disorders (van Harten, 1993; Joffe et al, 1998; Mendez et al, 2005). Citalopram is a fine, white powder that is sparingly soluble in water and soluble in ethanol It is available as filmcoated, round or oval, white, scored tablets containing citalopram hydrobromide, corresponding to 10, 20, 30 or 40 mg of citalopram base in the Mexican market. Due to its safety and efficacy, it is widely available in Mexico
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
