Pharmacokinetics of zonisamide dispersible tablets in healthy Chinese volunteers using an analytic method of HPLC
DAI Qing
CHEN Yong-chuan
QIU Xue-wen
XIANG Rong-feng
XIONG Li-rong
Abstract：Objective:To establish an HPLC method for the determination of zonisamide in human plasma, and study the pharmacokinetics of zonisamide dispersible tablets with single and multiple doses in healthy Chinese volunteers. Methods:Thirty healthy volunteers were randomly divided into three groups. The volunteers in the three groups were given single-dose of zonisamide dispersible tablets respectively with 200, 300 and 400 mg, and then those subjects in 300 mg single-dose zonisamide dispersible tablets group were enrolled for multiple-dose study, who were given zonisamide once a day for fourteen days. The plasma concentrations of zonisamide were determined by HPLC method, the pharmacokinetic parameters were calculated and analyzed by DAS 2.1.1 software. Results:AUC0-t, AUC0-∞and Cmax of zonisamide increased in a linear manner at the dose range from 200 to 400 mg. For the multiple-dose administration, the parameters were as follow:Cmax (27.305 ± 5.201) μg·mL-1, tmax (2.556 ± 0.726) h, t1/2 (59.286 ± 8.882) h, AUC0-t (2 435.713 ± 668.845) μg·h·mL-1, AUC0-∞(2 522.230 ± 720.554) μg·h·mL-1. Conclusion:Cmax showed signiifcant difference in physiological disposition between the male and female after administration of a single-dose. After the administration of multiple-dose zonisamide, steady state plasma concentrations can be achieved.
Keywords：ZonisamideHPLCPlasmaPharmacokinetics
Publication Date：2014-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 1-4 )