End-Stage Renal Disease
Conditions
Keywords
end-stage renal disease hemodialysis donepezil hydrochloride pharmacokinetics Cross-Over Study
Brief summary
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.
Detailed description
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.
Interventions
DRUGdonepezil 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.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameter: maximum drug concentration in plasma | 0-48 hours |
| Pharmacokinetics parameter: maximum drug concentration time in plasma | 0-48 hours |
| Pharmacokinetics parameter: area under the plasma concentration time curve from Time 0 to 48. | 0-48 hours |
Countries
Japan
Outcome results
None listed