Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.

End-Stage Renal Disease Clinical Trial

Official title:

Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063556
• Other study ID #: E2020-J081-107
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2010
• Last updated: May 13, 2013
• Start date: February 2010
• Est. completion date: March 2010

Study information

• Verified date: November 2010
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameter: maximum drug concentration in plasma		0-48 hours	No
Primary	Pharmacokinetics parameter: maximum drug concentration time in plasma		0-48 hours	No
Primary	Pharmacokinetics parameter: area under the plasma concentration time curve from Time 0 to 48.		0-48 hours	No