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Trial record 9 of 331 for:    DONEPEZIL

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

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ClinicalTrials.gov Identifier: NCT03259958
Recruitment Status : Completed
First Posted : August 24, 2017
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Corium International Inc.

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®

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Donepezil TDS Drug: Aricept Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Assess the Steady-State Bioequivalence of Once-Weekly Corplex™ 10mg Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept®
Actual Study Start Date : October 30, 2017
Actual Primary Completion Date : March 13, 2018
Actual Study Completion Date : March 14, 2018


Arm Intervention/treatment
Experimental: Donepezil TDS
Corplex Donepezil TDS 5 mg/day followed by Donepezil TDS 10mg/day applied weekly for 5 consecutive weeks
Drug: Donepezil TDS
Donepezil Hydrochloride Transdermal Delivery System

Active Comparator: Aricept
Aricept 5 mg/day followed by Aricept 10 mg/day once daily for 5 consecutive weeks
Drug: Aricept
Aricept Tablet




Primary Outcome Measures :
  1. 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 ]
    To assess the plasma concentration (AUC) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride [HCl]).

  2. 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 ]
    To assess the maximum observed concentrations (Cmax) of once-weekly Corplex Donepezil (TDS) compared to once-daily (QD) administration of Aricept (donepezil hydrochloride [HCl]).


Secondary Outcome Measures :
  1. 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 ]
    General Safety (AE and SAE as reported by subject following guidance CTCAE v4.0)

  2. PI assessment of local skin irritation response to TDS [ Time Frame: 0.5hr, 24hr, 48hr and 72hr after each TDS removal. (5 consecutive weeks) ]
    To evaluate the safety and tolerability (including local skin irritation) of once-weekly Corplex Donepezil TDS. Dermal Response assessed using 8 point categorical scale. Other effects assessed using a 6 point scale.

  3. PI assessment of TDS Adhesion [ Time Frame: Daily during 5 week treatment period ]
    Adhesion data will be collected during each 7-day patch wear period throughout 5 week treatment period. Percent adherence will be assessed using 12 point categorical scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Key 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259958


Locations
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United States, Arizona
Celerion Inc.
Phoenix, Arizona, United States, 85283
Sponsors and Collaborators
Corium International Inc.
Investigators
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Principal Investigator: Danielle Armas, MD Celerion

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Responsible Party: Corium International Inc.
ClinicalTrials.gov Identifier: NCT03259958     History of Changes
Other Study ID Numbers: P-16010
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Plans

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Donepezil
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents