Bioequivalence of two brands of citalopram 40 mg tablets after single oral administration to healthy volunteers.
A randomized, two-way, crossover, bioequivalence study was conducted in 26 fasting, healthy, male volunteers to compare two brands of citalopram 40 mg tablets, Citol (Abdi Ibrahim Ilaç San. ve Tic A.S., Istanbul, Turkey) as a test and Cipramil (H. Lundbeck A/S, Copenhagen, Denmark) as a reference product. One tablet of either formulation was administered with low-carbonate water after 10 h of overnight fasting. After dosing, serial blood samples were collected during a period of 24 hours. Plasma samples were analysed for citalopram by a validated HPLC method. The pharmacokinetic parameters AUC0-24, AUC(0-alpha), Cmax, Tmax, K(el), T(1/2), and CL were determined from plasma concentration-time profiles for both formulations and were compared statistically to evaluate bioequivalence between the two brands of citalopram, using the statistical modules recommended by FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals (CI) fell within the acceptable range for bioequivalence. Based on these statistical inferences it was concluded that the two brands exhibited comparable pharmacokinetics profiles and that Abdi Ibrahim's Citol is equivalent to Cipramil of H. Lundbeck, Copenhagen, Denmark.
Mendoza
Luis
L
I.Q.A., a.s., Jindricha Plachty 16, Prague 10, 150 00, Czech Republic. mendoza@iqa.cz
Hajdúch
Marián
M
Kekulová
Hana
H
Svobodová
Xenia
X
Mihál
Vladimír
V
Svoboda
Michal
M
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D015283:Citalopram / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D015283:Citalopram; D017367:Selective Serotonin Reuptake Inhibitors