中国临床药理学杂志Issue(3)：199-202,4.DOI:10.13699/j.cnki.1001-6821.2015.03.013
中国健康受试者口服非布司他片的药代动力学研究
Pharmacokinetics of oral administration of febuxostat tablet in Chinese healthy volunteers
摘要
Abstract
Objective To evaluate pharmacokinetics of febuxostat in Chinese healthy volunteers.Methods Twenty -four volunteers were assigned into two groups taking different doses (40, 80 mg) of febuxostat tablets.Subjects received single 40 mg and multiple 40 mg or single 80 mg doses of febuxostat tablets.Plasma samples were collected over 24 h and the plasma concentrations were determined by LC-MS/MS.Results After 40 mg and 80 mg single dose administration of febuxostat, Cmax were (1873.55 ±735.94) and (3899.17 ±1577.54) ng· mL-1, tmax were (1.86 ±1.10) and (2.15 ±1.75) h, t1/2 were (5.57 ±1.32) and (4.87 ±0.86) h, CL/F were (6.44 ±1.97) and (6.15 ±2.15) h· L-1, and AUC0-24 h were (6651.10 ±2319.72) and (1.43 ×104 ±5033.26) ng· h · mL-1 , respectively.Following febuxostat tablet at 40 mg dose daily for 5 consecutive days, the pharmacokinetic parameters in steady state were similar to those taking a single dose of this drug.Conclusion There was no significant difference in pharmacokinetics parameters of febuxostat adjusted by weight as compared with other races.So, clinical usage of febuxostat can refer to the foreign clinical regime.关键词
非布司他/高效液相串联质谱仪/药代动力学Key words
febuxostat/LC-MS/MS/pharmacokinetic分类
医药卫生引用本文复制引用
裘福荣,朱蕾蕾,蒋健,贺敏,赵彤芳,叶宇捷,沈淑娇,过林,王猛猛..中国健康受试者口服非布司他片的药代动力学研究[J].中国临床药理学杂志,2015,(3):199-202,4.基金项目
国家科技部新药重大创制基金资助项目（2012ZX09303009－001），上海中医临床重点实验室基金资助项目 （）
