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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| donepezil HCl | Drug | 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. |
| Measure | Description | 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hirotake Ishigami | Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moriya | Ibaraki | Japan |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| donepezil HCl | Drug | 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. |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |