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Pharmacokinetic Comparisons of Two Donepezil Formulations

NCT01297036 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2011-02-16

No results posted yet for this study

Summary

To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed donepezil formulation with a conventional formulation in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Donepezil, ODT 10 mg

Test- Donepezil Hydrochloride 10 mg Tablet single dose

DRUG

Donepezil, 10 mg tablet

Reference: Donepezil Hydrochloride 10 mg Tablet

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical Corp.

    collaborator INDUSTRY

  • Korea University Anam Hospital

    lead OTHER

Principal Investigators

  • Ji-Young Park, MD, PhD · Anam Hospital, Korea Univeristy College of Medicine

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-03-31
Completion
2008-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01297036 on ClinicalTrials.gov