STUDY OF THE PHARMACOKINETICS OF DOMESTIC ARIPIPRAZOLE IN HEALTHY VOLUNTEERS.

Objective:To determine aripiprazole in human plasma by developing a HPLC-UV method,and study the pharmacokinetics profiles of domestic aripiprazole tablets in healthy volunteers.Methods:The multiple oral doses of domestic aripiprazole were given to 14 healthy volunteers.Aripiprazole concentration in human plasma was determined by HPLC method.The pharmacokinetic parameters of aripiprazole were obtained with statistical analysis by DAS1.0.Result:In this study,the healthy volunteers took aripiprazole for 14 d to achieve steady state,and reached the peak concentration(480.3±126.2)μg·L~(-1) at(4.0±0.9)h after the last administration in steady state.AUC_(0-360h) was(38166.6±13241.2)μg·h·L~(-1),t_(1/2β) was(91.0±21.1h),CL/F was (0.62±0.36)L·h~(-1) and V/F was(60.9±43.7)L.Conclusion:The concentration-time curve of aripiprazole was conformed to a two-compartment open model.And it offered necessary information for clinical use of aripiprazole in Chinese.