Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.

Eisai

Status and phase: Completed; Phase 4

Conditions: End-Stage Renal Disease

Treatments: Drug: donepezil HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT01063556

E2020-J081-107

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: donepezil HCl

Drug: donepezil HCl

2

Experimental group

Treatment:

Drug: donepezil HCl

Drug: donepezil HCl