CompletedPhase 1

A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations

A Phase 1, Crossover Study to Evaluate the Pharmacokinetics of Corplex™ Donepezil 10 mg Transdermal Delivery System Applied to Different Body Locations

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, AUC•Pharmacokinetics, CMAX

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 IDNCT03432195

Org study IDP16012

Timeline

Milestones

Study start2018-01-31actual

Study first posted2018-02-14actual

Primary completion2018-06-28actual

Study completion2018-06-28actual

Last update posted2018-08-07actual

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

•Body mass index ≥ 18.0 and ≤ 32.0 kg/m2 at screening

•Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator

•Have a Fitzpatrick skin type of I, II or III or have skin colorimeter scores equivalent to the allowed Fitzpatrick skin type

Exclusion criteria

•History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (including piperidine derivatives and other cholinesterase inhibitors)

•Has intolerance to venipuncture and/or inability to comply with the extensive blood sampling required for this study or does not have suitable veins in both arms

•Potential for occupational exposure to anticholinesterase agents

•Estimated creatinine clearance in non-elderly subjects <80 mL/min at screening and in elderly subjects (i.e., ≥55 years of age) <60 mL/min at screening

•Hemoglobin value of less than 11.5 g/dl for females, 13.0 g/dl for males at screening and first check-in

•Muscle relaxants, anti-Parkinsonian or neuroleptic medications prior to the first dose of study drug

•History or presence of significant skin damage or other skin disturbances as deemed by the Investigator to potentially interfere with patch procedures

•Use of donepezil hydrochloride or related drugs within 60 days prior to the first study drug administration

•Clinically significant depression symptoms or suicidal ideation or behavior as determined by the Investigator

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, AUC

Time frame:Blood samples for donepezil PK will be collected pre-dose until the end of each treatment period, approximately 18 weeks total

concentration, descriptive

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 18 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 throughout the 5 week period

event count, event

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

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

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

descriptive

Secondary/protocol endpoint/low confidence

Application Site Mean Adhesion Scores of Donepezil Corplex 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.