Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.

NCT ID: NCT01063556

Last Updated: 2013-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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End-Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

donepezil HCl

Intervention Type 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.

2

Group Type EXPERIMENTAL

donepezil HCl

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hirotake Ishigami

Role: STUDY_DIRECTOR

Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Locations

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Moriya, Ibaraki, Japan

Site Status

Countries

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Japan

Other Identifiers

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E2020-J081-107

Identifier Type: -

Identifier Source: org_study_id

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