Relative Bioavailability And Bioequivalent Of Citalopram Tables In Healthy Volunteers

OBJECTIVE To determine the relative bioavailability and bioequivalence of citalopram tablets in the healthy male volunteers.METHODS Eighteen healthy male volunteers administered a dose of 40 mg either tested or reference citalopram hydrobromide tablets according to a randomized two way cross over design. The concentration of citalopram hydrobromide in plasma was determined by HPLC. The pharmacokinetic parameters were processed with SPSS 10.0 for variance analysis and two one-side t tests.RESULTS The pharmacokinetic parameters, AUC_0→144, AUC_{0→∞}, T_max and C_max of the trial preparation or the reference preparation were1665.0±318.3ng·h/ml和1670.6±346.2ng·h/ml,1806.0±371.6ng·h/ml和1822.9±404.7ng·h/ml,4.6±0.9h和4.6±1.4h,34.3±3.8ng/ml和35.2±4.3ng/ml respectively. The relative bioavailability was 100.5±10.8% No significant differences were found among the main pharmacokinetic parameters, and the two one-sided t-tests showed that the trial preparation and the reference preparation were bioequivalent.CONCLUSION The trial preparation were bioequivalent to the reference preparation.