CompletedPhase 1

A Bioequivalence Study of Corplex™ Donepezil Transdermal Delivery System Compared to Aricept®

A Study to Assess the Steady-State Bioequivalence of Once-Weekly Corplex™ 10mg Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept®

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

•PK, AUC•PK, 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 IDNCT03259958

Org study IDP-16010

Timeline

Milestones

Study first posted2017-08-24actual

Study start2017-10-30actual

Primary completion2018-03-13actual

Study completion2018-03-14actual

Last update posted2018-08-01actual

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.

•Female subjects with a positive pregnancy test or lactating

•Positive urine drug or alcohol results

•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

•Any of the following drugs for 28 days prior to the first dose of study drug in Treatment Period 1 and throughout the study:

-significant inducers of cytochrome P450 (CYP) enzymes and/or P-glycoprotein;

-anti-inflammatory drugs or cyclooxygenase 2 (COX-2) analgesic;

-beta-blockers;

-anti-fungal medications;

-anti-histamines;

-cholinergics and anti-cholinergics;

-oral corticosteroids;

-Prolia;

-adjuvant analgesics

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

•History or presence of excessive hairy skin on application sites as deemed by the Investigator to potentially interfere with drug absorption

•History or presence of significant skin damage, diffuse skin diseases, scars, tattoos on the application sites or other skin disturbances as deemed by the Investigator to potentially interfere with drug absorption or irritation assessments

•Use of donepezil hydrochloride or related drugs within 30 days prior to the first study drug administration

•Participation in another clinical study within 30 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 clinical outcomes

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

PK, AUC

Time frame:Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 weeks total

concentration, descriptive

Primary/protocol endpoint

PK, Cmax

Time frame:Blood samples for donepezil PK will be collected pre dose until the end of each treatment period, approximately 10 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 5 week treatment period and during the 5 week follow-on period

event count, event

Secondary/protocol endpoint

PI assessment of local skin irritation response to TDS

Time frame:0.5hr, 24hr, 48hr and 72hr after each TDS removal. (5 consecutive weeks)

descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

PI assessment of TDS Adhesion

Time frame:Daily during 5 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.