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ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Therapeutic Medicine, Ehime University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Kitasato University Research Center for Clinical Pharmacology, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Internal Medicine, Kasaoka Dai-ichi Hospital, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Clinical Pharmacology, Hirosaki University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Clinical Trial Support Center, Showa University Hospital, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Clinical Pharmacology and Therapeutics, Oita University School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Therapeutic Medicine, Ehime University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Clinical Trial Center, Kitasato University East Hospital, Japan
Asubio Pharma Co., Ltd., Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Integrated Medicine and Informatics, Ehime University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Integrated Medicine and Informatics, Ehime University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Integrated Medicine and Informatics, Ehime University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Therapeutic Medicine, Ehime University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Therapeutic Medicine, Ehime University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Therapeutic Medicine, Ehime University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Therapeutic Medicine, Ehime University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Kitasato University Research Center for Clinical Pharmacology, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Kitasato University Research Center for Clinical Pharmacology, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Kitasato University Research Center for Clinical Pharmacology, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Kitasato University Research Center for Clinical Pharmacology, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Kitasato University Research Center for Clinical Pharmacology, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Kitasato University Research Center for Clinical Pharmacology, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Kitasato University Research Center for Clinical Pharmacology, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Kitasato University Research Center for Clinical Pharmacology, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Kitasato University Research Center for Clinical Pharmacology, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Kitasato University Research Center for Clinical Pharmacology, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Kitasato University Research Center for Clinical Pharmacology, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Internal Medicine, Kasaoka Dai-ichi Hospital, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Clinical Pharmacology, Hirosaki University Graduate School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Clinical Trial Support Center, Showa University Hospital, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Clinical Trial Support Center, Showa University Hospital, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Clinical Trial Support Center, Showa University Hospital, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Clinical Trial Support Center, Showa University Hospital, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Clinical Trial Support Center, Showa University Hospital, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Clinical Trial Support Center, Showa University Hospital, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Clinical Pharmacology and Therapeutics, Oita University School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Clinical Pharmacology and Therapeutics, Oita University School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Clinical Pharmacology and Therapeutics, Oita University School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Clinical Pharmacology and Therapeutics, Oita University School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Clinical Pharmacology and Therapeutics, Oita University School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Clinical Pharmacology and Therapeutics, Oita University School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Clinical Pharmacology and Therapeutics, Oita University School of Medicine, Japan
ANTCliPh (Academic Network for Trials in Clinical Pharmacology) Trial 02 Study Group Department of Therapeutic Medicine, Ehime University Graduate School of Medicine, Japan
Article ID: 12043FP
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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 (CLCR): 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 (Cmax) was similar in the groups (12.66, 17.25, 15.75, and 15.83 ng/mL, respectively), as was mean time to Cmax (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.