Study on Pharmacokinetics of Itraconazole in Healthy Volunteers

Objective To study the pharmacokinetics of itraconazole capsules after a single oral dose in healthy volunteers.Methods Ten healthy male volunteers and ten healthy female volunteers were involved in the study.Each subject received a single dose of 200 mg itraconazole capsules.The plasma concentration was determined by HPLC.The pharmacokinetic parameters were calculated by DAS 2.0 software and statistically analyzed by SPSS 10.0 software.Results The main pharmacokinetic parameters were as follows:Cmax was(0.18±0.05) μg/ml,tmax was(3.81±0.35) h,t1/2 was(16.82±1.92) h,AUC0-72 was(2.63±2.41) μg · h/ml,AUC0-∞ was(3.16±2.19) μg · h/ml,and Ke was(0.14±0.05) h.Conclusion The plasma concentration-time curve of itraconazole conformed to one-compartment model.The main pharmacokinetic parameters of Cmax,t1/2 and Ke were not significantly different between male and female volunteers.