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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
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

February 1, 2010
February 5, 2010
May 14, 2013
February 2010
March 2010   (Final data collection date for primary outcome measure)
  • 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 ]
Pharmacokinetics parameters: maximum drug concentration in plasma, maximum drug concentration time in plasma, and area under the plasma concentration time curve from Time 0 to 48. [ Time Frame: 0-48 hours ]
Complete list of historical versions of study NCT01063556 on ClinicalTrials.gov Archive Site
Not Provided
Monitoring and recording all adverse events. [ Time Frame: 0-48 hours ]
Not Provided
Not Provided
 
Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.
Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
End-Stage Renal Disease
  • 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.
  • Experimental: 1
    Intervention: Drug: donepezil HCl
  • Experimental: 2
    Intervention: Drug: donepezil HCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
Same as current
March 2010
March 2010   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
20 Years to 79 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01063556
E2020-J081-107
Not Provided
Not Provided
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Hirotake Ishigami Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
Eisai Inc.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP