Pharmacokinetic Characteristics and Bioequivalence of Paroxetine Tablets in Healthy Chinese Volunteers

Objective To study the pharmacokinetic characteristics of paroxetine tablets in healthy Chinese volunteers and to compare the bioequivalence between two preparations of paroxetine tablets. Methods 20 healthy volunteers in a randomized crossover study were given each a single oral dose of 40 mg of test or reference paroxetine tablets.The plasma concentration of paroxetine was determined with HPLC. The pharmacokinetic parameters were calculated while the bioavailability and bioequivalence of the two preparations were evaluated with the P97 pharmacokinetic software. Results The main pharmacokinetic parameters for test and reference preparations were Cmax:(62.78±17.4) and(64.74±18.4) ng·mL-1;tmax:(5.1±1.7) and(5.64±1.84) h;t1/2:(19.85±5.72) and(20.0±5.) h;AUC0-120:(1 04.21±297.) and(1 076.47±09.49) ng·h-1·mL-1;AUC 0-inf:(1 58.5±44.7) and(1 86.75±476.54) ng·h-1·mL-1,respectively.The relative bioavailability of the test and reference preparations F0-120:(98.9±16.)% and F0-inf:(96.±18.2)%,respectively. Conclusion The two preparations of paroxetine tablets were shown to be bioequivalent.