Difference of Gender on Pharmacokinetics of Controlled-release Paroxetine Tablets in Healthy Chinese Subjects

Objective To study the difference of gender on pharmacokinetics of controlled-release paroxetine tablets in Chinese healthy subjects. Methods Fourteen male and ten female subjects received a single oral dose of25 mg controlled-release paroxetine tablets. The plasma concentration of paroxetine was determined by HPLC-MS /MS. The pharmacokinetic parameters were calculated by Win Nonlin 6. 3 software. Results The plasma concentration curve of paroxetine following a single oral dose administration was close between male and female subjects. The main pharmacokinetic parameters of paroxetine in male and female groups were: Cmax( 6. 06 ± 5. 43) and( 7. 20 ±4. 48) ng·ml-1,Tmax( 9. 14 ± 1. 70) and( 9. 60 ± 1. 84) h,t1 /2( 12. 59 ± 3. 15) and( 11. 57 ± 1. 14) h,AUC0-t( 164. 39 ± 194. 08) and( 176. 30 ± 111. 58) h·ng·ml-1,AUC0-inf( 168. 25 ± 201. 05) and( 177. 72 ± 112. 45)h·ng·ml-1,CL/F( 525. 99 ± 638. 78) and( 426. 95 ± 619. 41) L·h-1,respectively. There was no significant difference in pharmacokinetic parameters between male and female subjects( P > 0. 05). Conclusion There is no significant difference in pharmacokinetics between males and females.