Hoshide S, Takahashi Y, Ishikawa T, Kubo J, Tsuchimoto M, Komoriya K, Ohno I, Hosoya T
Teijin Ltd., Tokyo, Japan.
Nucleosides Nucleotides Nucleic Acids. 2004 Oct;23(8-9):1117-8. doi: 10.1081/NCN-200027377.
A single oral dose of 20 mg febuxostat was administered to subjects with normal, mild or moderate impairment in renal function. There was less than a 2-fold difference in AUC of plasma unchanged febuxostat among the renal function groups, and changes in plasma urate levels from pre-dose levels were not significant. A total of five adverse events were reported with all mild in severity. The results indicate that renal impairment will have little clinical impact on the pharmacokinetics (PK), pharmacodynamics (PD) and safety of the study drug.
对肾功能正常、轻度或中度受损的受试者口服单剂量20毫克非布司他。肾功能各亚组间血浆中非布司他原形的AUC差异小于2倍,且血浆尿酸水平相对于给药前水平的变化不显著。共报告了5例不良事件,均为轻度。结果表明,肾功能损害对研究药物的药代动力学(PK)、药效学(PD)和安全性几乎没有临床影响。