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

NCT ID: NCT03259958

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-30
• Study Completion Date: 2018-03-14

Brief Summary

A study to assess the steady-state bioequivalence of once-weekly Corplex™ Donepezil 10 mg Transdermal Delivery System (TDS) compared to daily administration of Aricept®

Detailed Description

Open label, randomized, 2-period, multiple-dose crossover study.

Approximately 86 healthy, adult male and female subjects will be enrolled.

Subjects will be randomized to 1 of 2 treatment sequences prior to the first study product treatment in treatment period 1.

For each treatment period; subjects will receive donepezil for 5 consecutive weeks. Blood samples for donepezil PK will be collected pre-dose through week 10.

Adhesion and skin irritation will be monitored throughout TDS treatments. Safety will be monitored throughout the study by adverse event reporting, repeated clinical and laboratory evaluations.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Donepezil TDS

Corplex Donepezil TDS 5 mg/day followed by Donepezil TDS 10mg/day applied weekly for 5 consecutive weeks

Group Type: EXPERIMENTAL

Donepezil TDS

Intervention Type: DRUG

Donepezil Hydrochloride Transdermal Delivery System

Aricept

Aricept 5 mg/day followed by Aricept 10 mg/day once daily for 5 consecutive weeks

Group Type: ACTIVE_COMPARATOR

Aricept

Intervention Type: DRUG

Aricept Tablet

Interventions

Donepezil TDS

Donepezil Hydrochloride Transdermal Delivery System

Intervention Type: DRUG

Aricept

Aricept Tablet

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Corium, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Armas, MD

Role: PRINCIPAL_INVESTIGATOR

Celerion

Locations

Celerion Inc.

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

P-16010

Identifier Type: -

Identifier Source: org_study_id