Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01063556
First received: February 1, 2010
Last updated: May 13, 2013
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
End-Stage Renal Disease
Drug: donepezil HCl
Drug: donepezil HCl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Pharmacokinetics parameter: maximum drug concentration in plasma [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
  • Pharmacokinetics parameter: maximum drug concentration time in plasma [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
  • Pharmacokinetics parameter: area under the plasma concentration time curve from Time 0 to 48. [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Experimental: 2 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01063556

Locations
Japan
Moriya, Ibaraki, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Hirotake Ishigami Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01063556     History of Changes
Other Study ID Numbers: E2020-J081-107
Study First Received: February 1, 2010
Last Updated: May 13, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
end-stage renal disease hemodialysis donepezil hydrochloride pharmacokinetics Cross-Over Study

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014