NCT01297036

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 alzheimer-disease

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_1 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
Last Updated

February 16, 2011

Status Verified

January 1, 2008

Enrollment Period

2 months

First QC Date

February 15, 2011

Last Update Submit

February 15, 2011

Conditions

Alzheimer Disease

Keywords

PharmacokineticsBioequivalenceDonepezil

Outcome Measures

Primary Outcomes (3)

  • donepezil pharmacokinetics: peak plasma concentrations (Cmax)

    240 hours

  • donepezil pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to 240 hr(AUCall)

    240 hours

  • donepezil pharmacokinetics: Area under the time vs. plasma concentration curve from 0 to infinity(AUCinf)

    240 hours

Study Arms (2)

Reference arm

ACTIVE COMPARATOR

Treated with Reference (Aricept, 10 mg donepezil tablet)

Drug: Donepezil, 10 mg tablet

Test arm

EXPERIMENTAL

Treated with Test (Neuropezil, 10 donepezil ODT, orally disintegrating tablet)

Drug: Donepezil, ODT 10 mg

Interventions

Donepezil, ODT 10 mgDRUG

Test- Donepezil Hydrochloride 10 mg Tablet single dose

Also known as: Neuropezil ODS, developed by Chong Kun Dang Co, Ltd.
Test arm
Donepezil, 10 mg tabletDRUG

Reference: Donepezil Hydrochloride 10 mg Tablet

Also known as: Aricept:, Manufactured by Dae Woong harm. Co. Ltd, Seoul, Korea
Reference arm

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males age 20 to 45 years
  • Body weight \> 45 kg with +/- 20% of ideal body weight
  • Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations

You may not qualify if:

  • subjects with acute conditions.
  • presence of history affecting ADME
  • Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
  • Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
  • Any other acute or chronic disease
  • A history of hypersensitivity to donepezil
  • A history of alcohol or drug abuse
  • Participation in another clinical trial within 3 months
  • smoked \>10 cigarettes daily
  • consumption over 5 glasses daily of beverages containing xanthine derivatives
  • use of any medication having the potential to affect the study results within 10 days before the start of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine

Seoul, Seoul, 136-705, South Korea

Location

Related Publications (1)

  • Kim KA, Lim JL, Kim C, Park JY. Pharmacokinetic comparison of orally disintegrating and conventional donepezil formulations in healthy Korean male subjects: a single-dose, randomized, open-label, 2-sequence, 2-period crossover study. Clin Ther. 2011 Jul;33(7):965-72. doi: 10.1016/j.clinthera.2011.06.003. Epub 2011 Jul 2.

    PMID: 21723605DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

DonepezilLong-Term Synaptic DepressionTablets

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsNeuronal PlasticityNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDosage FormsPharmaceutical Preparations

Study Officials

  • Ji-Young Park, MD, PhD

    Anam Hospital, Korea Univeristy College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 16, 2011

Study Start

January 1, 2008

Primary Completion

March 1, 2008

Study Completion

May 1, 2008

Last Updated

February 16, 2011

Record last verified: 2008-01

Locations

KR(1)