Back to resultsPharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.
Primary Purpose
End-Stage Renal Disease
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
donepezil HCl
donepezil HCl
Sponsored by
About this trial
This is an interventional treatment trial for End-Stage Renal Disease focused on measuring end-stage renal disease hemodialysis donepezil hydrochloride pharmacokinetics Cross-Over Study
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetics parameter: maximum drug concentration in plasma
Pharmacokinetics parameter: maximum drug concentration time in plasma
Pharmacokinetics parameter: area under the plasma concentration time curve from Time 0 to 48.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01063556
Brief Title
Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.
Official Title
Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
end-stage renal disease hemodialysis donepezil hydrochloride pharmacokinetics Cross-Over Study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
donepezil HCl
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
donepezil HCl
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pharmacokinetics parameter: maximum drug concentration in plasma
Time Frame
0-48 hours
Title
Pharmacokinetics parameter: maximum drug concentration time in plasma
Time Frame
0-48 hours
Title
Pharmacokinetics parameter: area under the plasma concentration time curve from Time 0 to 48.
Time Frame
0-48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hirotake Ishigami
Organizational Affiliation
Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Moriya
State/Province
Ibaraki
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.
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