Title: Relative Bioavailability and Bioequivalent of Citalopram Tables in Healthy Volunteers
Abstract: Objective To determine the relative bioavailability and bioequivalence of citalopram tablets in the healthy male volunteers.Methods Eighteen healthy male volunteers were equally and ramdomly divided into two groups administered a dose of 40 mg either tested or reference citalopram hydrobromide tablets. 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,AUC0→144,AUC0→∞,Tmax and Cmax of the trial preparation or the reference preparation were 1665±318 ng·h/mL and 1671±346 ng·h/mL,1806±372 ng·h/mL and 1823 ± 405 ng·h/mL,4.6±0.9 h and 4.6±1.4 h,34.3±3.8 ng/mL and 35.2±4.3 ng/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.
Publication Year: 2007
Publication Date: 2007-01-01
Language: en
Type: article
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