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CompletedPhase 1

Pharmacokinetic Comparisons of Two Donepezil Formulations

Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Donepezil Between Two Donepezil Products, Aricept® Tablet and Neuropezil ODT, in Healthy Subjects

Asset

Donepezil

Listed sites

1

Recruiting sites

-

Enrollment

22

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 20-45•Male

Primary endpoint

•Donepezil pharmacokinetics

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID121HPS07D_03
NCT IDNCT01297036

Timeline

Milestones

Study start2008-01 (month precision)
Primary completion2008-03actual (month precision)
Study completion2008-05actual (month precision)
Study first posted2011-02-16estimated
Last update posted2011-02-16estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age20 Years
Maximum age45 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

•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

Exclusion criteria

•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.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

donepezil pharmacokinetics: peak plasma concentrations (Cmax)

Time frame:240 hours

concentration, descriptive

Primary/protocol endpoint

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

Time frame:240 hours

concentration, descriptive

Primary/protocol endpoint

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

Time frame:240 hours

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.