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Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.

Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End-Stage Renal Disease

Intervention: donepezil HCl (Drug); donepezil HCl (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eisai Co., Ltd.

Official(s) and/or principal investigator(s):
Hirotake Ishigami, Study Director, Affiliation: Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Summary

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.

Clinical Details

Official title: Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Pharmacokinetics parameter: maximum drug concentration in plasma

Pharmacokinetics parameter: maximum drug concentration time in plasma

Pharmacokinetics parameter: area under the plasma concentration time curve from Time 0 to 48.

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

Minimum age: 20 Years. Maximum age: 79 Years. Gender(s): Both.

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.

Locations and Contacts

Moriya, Ibaraki, Japan
Additional Information

Starting date: February 2010
Last updated: May 13, 2013

Page last updated: August 20, 2015

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