CompletedPhase 1

A Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil Transdermal Delivery System (TDS)

A Phase 1, 2-Way Crossover Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil 5 mg Transdermal Delivery System (TDS) in Healthy Volunteers

Lead sponsor

Corium, Inc.

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥30

Primary endpoints

•Pharmacokinetics, Cmax•Pharmacokinetics, AUC

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

NCT IDNCT03438604

Org study IDP-16039

Timeline

Milestones

Study start2018-02-13actual

Study first posted2018-02-19actual

Primary completion2018-06-19actual

Study completion2018-06-30actual

Last update posted2018-09-14actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age30 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy, adult, male or female ≥ 30 years of age

Exclusion criteria

•History of any illness that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study

•History or presence of alcoholism or drug abuse within the past 2 years prior to the first study product treatment

•History or presence of hypersensitivity or idiosyncratic reaction to the study products or related compounds

•History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs

•History or presence of excessive sweating

•History or presence of hairy skin on application sites

•History or presence of significant skin damage or disease at application sites

•Any medical or surgical procedure or trauma within 28 days prior to the first study product treatment

Endpoints (5)

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.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Pharmacokinetics, Cmax

Time frame:Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics, AUC

Time frame:Blood samples for the Donepezil PK will be collected pre-dose until the end of each treatment period, approximately 6 weeks total

concentration, descriptive

Secondary/protocol endpoint

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame:Daily during 1 week treatment period and during the 5 week follow-on period

event count, event

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Summary Listing of Skin Irritation Score of Donepezil TDS by post-removal time point

Time frame:0.5 hr, 24 hr, 48 hr, 72 hr after each TDS removal (3 days)

descriptive

Secondary/protocol endpoint/low confidence

Application Site Mean Adhesion Scores of Donepezil TDS

Time frame:Daily during 1 week treatment period

descriptive

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.