Pharmacokinetics of Teneligliptin in Subjects With Renal Impairment

被引:33
作者
Halabi, Atef [1 ]
Maatouk, Haidar [1 ]
Siegler, Karl Ernst [2 ]
Faisst, Nadja [2 ]
Lufft, Volkmar [3 ]
Klause, Norbert [3 ]
机构
[1] CRS Clin Res Serv Kiel GmbH, Kiel, Germany
[2] CRS Clin Res Serv Mannheim GmbH, D-67269 Grunstadt, Germany
[3] Nephrol Zentrum, Rendsburg, Germany
来源
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT | 2013年 / 2卷 / 03期
关键词
teneligliptin; MP-513; DPP-IV inhibitor; renal impairment; end stage renal disease; pharmacokinetics; TYPE-2; SITAGLIPTIN; PREDICTION; CREATININE;
D O I
10.1002/cpdd.29
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The pharmacokinetics of teneligliptin was compared in renally impaired and healthy subjects. Subjects were assigned to one of four groups of eight subjects, according to the stage of disease [mild, moderate, severe or end stage renal disease (ESRD)], while matched healthy subjects were allocated to one of two reference groups. Mild, moderate and severe renal impairment had no effect on maximum plasma concentration (C-max) following a single oral dose of 20 mg teneligliptin, as defined in the FDA guideline. AUC(0-infinity) was increased in all groups relative to the reference group but this was unrelated to the degree of renal impairment. Mean plasma protein binding was <80% in all groups. Overall, teneligliptin was well tolerated by subjects with renal impairment or ESRD. Dialysis is not expected to affect the efficacy or safety of teneligliptin. These results indicate that dose adjustment may not be needed when teneligliptin is administered to subjects with mild, moderate or severe renal impairment or ESRD.
引用
收藏
页码:246 / 254
页数:9
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