Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.
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|ClinicalTrials.gov Identifier: NCT01063556|
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : May 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|End-Stage Renal Disease||Drug: donepezil HCl||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
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.
Drug: donepezil HCl
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063556
|Moriya, Ibaraki, Japan|
|Study Director:||Hirotake Ishigami||Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.|