Effect of Renal Impairment on the Pharmacokinetics of Memantine
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概要
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The effect of renal impairment on the pharmacokinetics of a single oral dose of memantine (10 mg) was determined in Japanese subjects. Subjects were assigned to four groups based on baseline creatinine clearance (CL<SUB>CR</SUB>): normal renal function (> 80 mL/min, n = 6), and mild (50 to ≤ 80 mL/min, n = 6), moderate (30 to < 50 mL/min, n = 6), and severe renal impairment (5 to < 30 mL/min, n = 7). Mean memantine maximum plasma concentration (C<SUB>max</SUB>) was similar in the groups (12.66, 17.25, 15.75, and 15.83 ng/mL, respectively), as was mean time to C<SUB>max</SUB> (6.2, 5.2, 4.3, and 5.4 h, respectively). However, exposure to memantine determined from mean area under the plasma concentration–time curve was 1.62-, 1.97-, and 2.33-times higher in subjects with mild, moderate, and severe renal impairment, respectively, as compared to controls with normal renal function. Mean memantine plasma elimination half-life increased according to increasing renal impairment (61.15, 83.00, 100.13, and 124.31 h, respectively), while mean cumulative urinary recovery of unchanged memantine in 72 h after dosing decreased according to increasing renal impairment (33.68%, 33.47%, 23.60%, and 16.17%, respectively). These results are the same as those in the previous study on caucasian individuals, when compared per body weight. It is suggested that the dose of memantine should be halved in patients with renal impairment.
- 2012-08-20
著者
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OHASHI Kyoichi
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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Moritoyo Takashi
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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Hasunuma Tomoko
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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Harada Kazuhiro
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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TATEISHI Tomonori
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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WATANABE Makoto
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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KOTEGAWA Tsutomu
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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NAGAI Masahiro
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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KUMAGAI Yuji
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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FUJITANI Tomomichi
Asubio Pharma Co., Ltd.
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OKURA Takahumi
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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FUKUOKA Tomikazu
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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MIYOSHI Kenichi
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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MATSUURA Bunzo
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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FURUKAWA Shinya
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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KOBORI Tomoe
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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MORITOYO Hiroyoko
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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NISHIKAWA Noriko
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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TSUJII Tomoaki
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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IWAKI Hirotaka
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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NAKAMURA Masahiko
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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MAKINO Satoshi
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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OHNUMA Kei
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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YUJI Koichiro
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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HASHIMOTO Megumi
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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TAKASU Masaru
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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HASHIZUME Yutaka
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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YOU Koji
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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MATSUMURA Tomoko
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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TANAKA Yuji
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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MATSUMOTO Nahoko
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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NAKAMURA Junichi
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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MIURA Jun
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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AKIZAWA Tadao
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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KITAZAWA Kozo
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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SHIBATA Takanori
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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KUROKI Aki
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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HONDA Hirokazu
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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MUKAI Masanori
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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MORIMOTO Takuya
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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IMAI Hiromitsu
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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OKUDAIRA Toshiaki
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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SATO Fuminori
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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IMANAGA Junko
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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TANAKA Katsuhiro
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group
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NOMOTO Masahiro
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group