Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.

Phase 4

Completed

• Conditions: End-Stage Renal Disease
• Interventions: Drug: donepezil HCl

• Registration Number: NCT01063556
• Lead Sponsor: Eisai Co., Ltd.

Brief 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.

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-11
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	donepezil HCl	-
1	donepezil HCl	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics parameter: maximum drug concentration in plasma	0-48 hours
Pharmacokinetics parameter: maximum drug concentration time in plasma	0-48 hours
Pharmacokinetics parameter: area under the plasma concentration time curve from Time 0 to 48.	0-48 hours