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건강한 한국 성인 자원자에서 Zonisamide의 약동학
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  • 건강한 한국 성인 자원자에서 Zonisamide의 약동학
저자명
이경훈,Lee. Kyung-Hoon
간행물명
臨床藥理學會誌= The journal of Korean Society for Clinical Pharmacology and Therapeutics
권/호정보
2006년|14권 1호|pp.51-57 (7 pages)
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대한임상약리학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Zonisamide has been used for various types of epilepsy, especially for refractory epilepsy. Method: An open-label, one-period, single-dose study was performed in 10 healthy Korean male volunteers with the approval of an institutional review board to determine the pharmacokinetics of zonisamide after a single 100 mg oral dose of zonisamide. Serial blood samples were obtained at fixed time points, over 216 h (baseline (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 72, 120, 168, and 216 h after administration). Zonisamide concentrations in plasma were measured by reversed-phase high-performance liquid chromatography (HPLC) with ultraviolet (UV) detector set at an wavelength of 280 nn. The results of the plasma analyses were subjected to non-compartmental pharmacokinetic analysis. Results: The maximum observed plasma zonisamide concentration $(C_{max});was;1.3{pm}0.3;(mean{pm}standard;deviation){mu}g/mL;at;4.0{pm}1.6hr$ of time to reach maximum observed plasma concentration $(T_{max})$. The value of area under the plasma zonisamide concentration versus time curve from the dosing to the last quantifiable concentration $(AUC_{0-last}=87.7{pm}15.6{mu}g{cdot}h/mL)$ was about 82% of AUC from the dosing to time infinity $(AUC_{0-{infty}}=106.8{pm}22.3{mu}g{cdot}h/mL)$. The calculated mean residence time (MRT) of zonisamide in the body was $128.6{pm}23.7h$, and the means of apparent oral total body clearance (CL/F) and volume of distribution $(V_dF)4 were $0.97{pm}0.21L/h;and;1.9{pm}0.3L/kg$, respectively. Conclusion: The present pharmacokinetic data of zonisamide would be useful for designing clinical trials including the bioequivalence test in Koreans.