A Phase 4 interventional study of donepezil HCl and donepezil HCl in End-Stage Renal Disease, sponsored by Eisai Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2013-05-14.
Sponsored by Eisai Co., Ltd. · Phase 4, Interventional, and Treatment
The purpose of this study is to investigate the pharmacokinetics of donepezil HCl 3 mg in subjects with end-state renal disease who were receiving haemodialysis.
This is a randomised, single-center, open-label, single-dose, two-period crossover pharmacokinetics study of donepezil HCl tablets 3 mg in subjects receiving haemodialysis. Subjects will be or will not be receiving haemodialysis. After intervals of over 15 days, the subjects will be receiving the other treatment.
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This study's enrollment of 6 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Subjects with end-stage renal disease who were receiving haemodialysis. Subject who are able and willing to give written informed consent.
Exclusion criteria:
Subjects with known hypersensitivity to drugs or foods. Subjects with a corrected QT interval greater than 450 msec at Screening period.
Drug: donepezil HCl
Drug: donepezil HCl
Subjects will receive donepezil HCL 3 mg without haemodialysis. After an interval of over 15 days, the subjects will receive donepezil 3 mg with haemodialysis.
Subjects will receive donepezil HCl 3 mg with haemodialysis. After an interval of over 15 days, the subjects will receive donepezil 3 mg without haemodialysis.
Pharmacokinetics parameter: maximum drug concentration in plasma
Time frame: 0-48 hours
Pharmacokinetics parameter: maximum drug concentration time in plasma
Time frame: 0-48 hours
Pharmacokinetics parameter: area under the plasma concentration time curve from Time 0 to 48.
Time frame: 0-48 hours
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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Eisai Co., Ltd.