<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02968719</url>
  </required_header>
  <id_info>
    <org_study_id>P-15086</org_study_id>
    <nct_id>NCT02968719</nct_id>
  </id_info>
  <brief_title>A Phase 1, Corplex™ Donepezil Transdermal System Compared to Oral Aricept®</brief_title>
  <official_title>Phase 1 Pharmacokinetic (PK) Study to Evaluate Once-weekly Corplex™ Donepezil Transdermal Delivery System Compared to Daily Oral Administration of Aricept® in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corium, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corium, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate&#xD;
      the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil&#xD;
      Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in Healthy&#xD;
      Adult Subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part A:&#xD;
&#xD;
      60 male and female subjects will be enrolled Subjects will receive 2 versions of once-weekly&#xD;
      Corplex Donepezil TDS and QD oral Aricept; each administered for 35 days in 3 different&#xD;
      treatment periods.&#xD;
&#xD;
      For each treatment period; Subjects will receive a lead-in dose of approximately 5 mg&#xD;
      donepezil/day for 7 days before commencing a dose of 10 mg donepezil/day for 28 days. Blood&#xD;
      samples for donepezil PK and red blood cell (RBC) AChEI (as a potential pharmacodynamic [PD]&#xD;
      marker) will be collected pre-dose through Week 8.&#xD;
&#xD;
      Adhesion and skin irritation will be monitored throughout TDS Treatments. A washout period of&#xD;
      at least 21 days between the last study drug administration (oral administration or removal&#xD;
      of TDS, as appropriate) in each treatment period and the first application of TDS or oral&#xD;
      drug administration, as appropriate, in the following treatment period.&#xD;
&#xD;
      Safety will be monitored throughout the study by adverse event reporting, repeated clinical&#xD;
      and laboratory evaluations&#xD;
&#xD;
      Part B:&#xD;
&#xD;
      Up to 47 subjects male and/or female will be enrolled This is an open-label, randomized,&#xD;
      2-way crossover sub-study. Eligible subjects will be randomized to 1 of 2 treatment sequences&#xD;
      prior to the first TDS application.&#xD;
&#xD;
      Subjects will receive 2 different once-weekly Corplex Donepezil TDS treatments (Treatments D&#xD;
      and E), each administered for 1 week, in 2 different treatment periods (Treatment Period 1&#xD;
      and Treatment Period 2).&#xD;
&#xD;
      In each treatment period, subjects will receive a target dose of 5 mg donepezil/day for 7&#xD;
      days. There will be a washout period of 35 days between removal of the first TDS in Treatment&#xD;
      Period 1 and application of the second TDS in Treatment Period 2.&#xD;
&#xD;
      Blood samples for donepezil PK will be collected pre-dose and through to Week 6 of each&#xD;
      treatment period.&#xD;
&#xD;
      Safety will be monitored throughout the sub-study by repeated clinical, skin irritation and&#xD;
      laboratory evaluations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">July 11, 2017</completion_date>
  <primary_completion_date type="Actual">July 11, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Steady-state PK</measure>
    <time_frame>TDS PK sampling time-points: Predose; Day 1 (hr0); Post-dose; Day 1 (hr2,6,12); Day 2-15,22 (hr0); Day 29 (hr0,3,6,12); Day 30-35 (hr0,12) Day 36 (hr0, 2,6,12); Day 37-38,41,44,47,50,54 (hr0);</time_frame>
    <description>To evaluate the steady-state PK of donepezil following once weekly Corplex Donepezil TDS application compared to once-daily (QD) oral administration of Aricept.&#xD;
Aricept PK sampling time points; Day 1 (hr0,1,2,3,4,6,8,12); Day 2,8,15,22,29 (hr0); Day 35(hr0,1,2,3,4,6,8,12); Day 36-37,40,43,46,49,53 (hr0)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK (Part B)</measure>
    <time_frame>TDS PK sampling time-points: Predose; Day 1 (hr0); Post-dose; Day 1 (hr2,6,12); Day 2-8 (hr0,12); Day 9,10,11,13,16,19,22,26,30,36 (hr0)</time_frame>
    <description>To compare the PK of 2 once-weekly Corplex Donepezil TDS treatments (target dose 5 mg donepezil/day)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (Part A and B)</measure>
    <time_frame>Daily during 36-day confinement period and 7 visits over the 21 day wash-out period.</time_frame>
    <description>General Safety (AE and SAE as reported by subject following guidance CTCAE v4.0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PI assessment of local skin irritation response to TDS (Part A and B)</measure>
    <time_frame>Part A: Daily during 36-day confinement period and 7 visits over the 21 day wash-out period. Part B:Daily during 10-day confinement period and 8 visits over the 28-35 day wash-out period.</time_frame>
    <description>To evaluate the safety and tolerability (including local skin irritation) of once-weekly Corplex Donepezil TDS. Skin irritation assessed using 8 pt categorical scale based on former FDA.gov/ohrms/dockets/98fr/990236GD.pdf. The Skin Irritation scale is: no irritation; minimal erythema/barely perceptible; definite erythema readily visible, minimal edema or minimal papular response; erythema and papules; definite edema; erythema, edema and papules; vesicular eruption; strong reaction spreading beyond application site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PI assessment of TDS Adhesion per FDA UCM504157</measure>
    <time_frame>Twice daily during 36-day confinement period</time_frame>
    <description>To evaluate the adhesion of once-weekly Corplex Donepezil TDS. Adhesion is based on the adhered area (%) of the patch according to FDA.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/UCM504157.pdf. Specifically: ≥ 90% adhered (essentially no lift off skin); ≥ 75% to &lt;90% adhered (some edges only lifting off skin); ≥ 50% to &lt;75% adhered (less than half the TDS lifting off skin); &lt; 50% adhered but did not detach (not detached, but more than half of the TDS lifting off skin without falling off); patch completely detached (TDS detached, completely off skin).</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Donepezil TDS Version A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lead-in of 5 mg/day donepezil of target dose (1 x Corplex 5 mg donepezil transdermal delivery system; 7 days) followed by; Target dose of 10 mg/day donepezil (Treatment A); Corplex 10 mg donepezil transdermal delivery system.&#xD;
1x patch will be worn for 7 days. A total of 4 TDS patches will be applied for 4 consecutive 7 day periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Donepezil TDS Version B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lead-in of 5 mg/day donepezil of target dose (1 x Corplex 5 mg donepezil transdermal delivery system; 7 days) followed by; Target dose of 10 mg/day donepezil (Treatment B); Corplex 10 mg donepezil delivery transdermal system.&#xD;
1x patch will be worn for 7 days. A total of 4 TDS patches will be applied for 4 consecutive 7 day periods.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 mg Aricept</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 mg/day oral Aricept, once daily for 7 days followed by; 10 mg/day Aricept once daily for 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Donepezil TDS Version D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Target dose of 5 mg/day donepezil (Treatment D) Corplex 5 mg Donepezil TDS applied for a duration of 1 week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Donepezil TDS Version E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Target dose of 5 mg/day donepezil (Treatment E) Corplex 5 mg Donepezil TDS applied for a duration of 1 week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Donepezil TDS Version A</intervention_name>
    <description>Donepezil Hydrochloride Transdermal Delivery System (5mg and 10 mg Version B)</description>
    <arm_group_label>10 mg Aricept</arm_group_label>
    <arm_group_label>Donepezil TDS Version B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Donepezil TDS Version B</intervention_name>
    <description>Donepezil Hydrochloride Transdermal Delivery System (5 mg and 10 mg Version B)</description>
    <arm_group_label>10 mg Aricept</arm_group_label>
    <arm_group_label>Donepezil TDS Version A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aricept</intervention_name>
    <description>Aricept (5 mg and 10 mg) Donepezil Hydrochloride</description>
    <arm_group_label>Donepezil TDS Version A</arm_group_label>
    <arm_group_label>Donepezil TDS Version B</arm_group_label>
    <other_name>Aricept Tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Donepezil TDS Version D</intervention_name>
    <description>Donepezil Hydrochloride Transdermal Delivery System (5 mg Version D)</description>
    <arm_group_label>Donepezil TDS Version D</arm_group_label>
    <arm_group_label>Donepezil TDS Version E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Donepezil TDS Version E</intervention_name>
    <description>Donepezil Hydrochloride Transdermal Delivery System (5 mg Version E)</description>
    <arm_group_label>Donepezil TDS Version D</arm_group_label>
    <arm_group_label>Donepezil TDS Version E</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, adult, Caucasian, male or female ≥18 years of age at screening&#xD;
&#xD;
          -  Body mass index ≥ 18.0 and ≤ 32.0 kg/m2 at screening&#xD;
&#xD;
          -  Medically healthy with no clinically significant medical history, physical&#xD;
             examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed&#xD;
             by the Investigator.&#xD;
&#xD;
          -  Have a Fitzpatrick skin type of I, II or III or have skin colorimeter scores&#xD;
             equivalent to the allowed Fitzpatrick skin type.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of hypersensitivity or idiosyncratic reaction to the study drugs&#xD;
             or related compounds (including piperidine derivatives and other cholinesterase&#xD;
             inhibitors)&#xD;
&#xD;
          -  Has intolerance to venipuncture and/or inability to comply with the extensive blood&#xD;
             sampling required for this study or does not have suitable veins in both arms&#xD;
&#xD;
          -  Potential for occupational exposure to anticholinesterase agents.&#xD;
&#xD;
          -  Female subjects with a positive pregnancy test or lactating&#xD;
&#xD;
          -  Positive urine drug or alcohol results&#xD;
&#xD;
          -  Estimated creatinine clearance in non-elderly subjects &lt;80 mL/min at screening and in&#xD;
             elderly subjects (i.e., ≥55 years of age) &lt;60 mL/min at screening&#xD;
&#xD;
          -  Hemoglobin value of less than 11.5 g/dl for females, 13.0 g/dl for males at screening&#xD;
             and first check-in&#xD;
&#xD;
          -  Any of the following drugs for 28 days prior to the first dose of study drug in&#xD;
             Treatment Period 1 and throughout the study:&#xD;
&#xD;
               -  significant inducers of cytochrome P450 (CYP) enzymes and/or P-glycoprotein&#xD;
&#xD;
               -  anti-inflammatory drugs or cyclooxygenase 2 (COX-2) analgesic&#xD;
&#xD;
               -  beta-blockers;&#xD;
&#xD;
               -  anti-fungal medications;&#xD;
&#xD;
               -  anti-histamines;&#xD;
&#xD;
               -  cholinergics and anti-cholinergics;&#xD;
&#xD;
               -  oral corticosteroids;&#xD;
&#xD;
               -  Prolia;&#xD;
&#xD;
               -  Adjuvant analgesics&#xD;
&#xD;
          -  Muscle relaxants, anti-Parkinsonian or neuroleptic medications prior to the first dose&#xD;
             of study drug&#xD;
&#xD;
          -  History or presence of excessive hairy skin on application sites as deemed by the&#xD;
             Investigator to potentially interfere with drug absorption&#xD;
&#xD;
          -  History or presence of significant skin damage, diffuse skin diseases, scars, tattoos&#xD;
             on the application sites or other skin disturbances as deemed by the Investigator to&#xD;
             potentially interfere with drug absorption or irritation assessments&#xD;
&#xD;
          -  Use of donepezil hydrochloride or related drugs within 60 days prior to the first&#xD;
             study drug administration&#xD;
&#xD;
          -  Participation in another clinical study within 60 days prior to the first study drug&#xD;
             administration&#xD;
&#xD;
          -  Clinically significant depression symptoms or suicidal ideation or behavior as&#xD;
             determined by the investigator:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Danielle Armas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Celerion</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 13, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>July 31, 2018</last_update_submitted>
  <last_update_submitted_qc>July 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Donepezil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No Plans</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02968719
org study id: P-15086
nct id: NCT02968719
lead sponsor: 
has dmc: No
A Phase 1, Randomized, Open-Label, 3-Way Crossover, Pilot, Pharmacokinetic Study to Evaluate
      the Steady State Pharmacokinetics of a Once-Weekly Application of Corplex Donepezil
      Transdermal Delivery System (TDS) Compared to Daily Oral Administration of Aricept in Healthy
      Adult Subjects
Part A:

      60 male and female subjects will be enrolled Subjects will receive 2 versions of once-weekly
      Corplex Donepezil TDS and QD oral Aricept; each administered for 35 days in 3 different
      treatment periods.

      For each treatment period; Subjects will receive a lead-in dose of approximately 5 mg
      donepezil/day for 7 days before commencing a dose of 10 mg donepezil/day for 28 days. Blood
      samples for donepezil PK and red blood cell (RBC) AChEI (as a potential pharmacodynamic [PD]
      marker) will be collected pre-dose through Week 8.

      Adhesion and skin irritation will be monitored throughout TDS Treatments. A washout period of
      at least 21 days between the last study drug administration (oral administration or removal
      of TDS, as appropriate) in each treatment period and the first application of TDS or oral
      drug administration, as appropriate, in the following treatment period.

      Safety will be monitored throughout the study by adverse event reporting, repeated clinical
      and laboratory evaluations

      Part B:

      Up to 47 subjects male and/or female will be enrolled This is an open-label, randomized,
      2-way crossover sub-study. Eligible subjects will be randomized to 1 of 2 treatment sequences
      prior to the first TDS application.

      Subjects will receive 2 different once-weekly Corplex Donepezil TDS treatments (Treatments D
      and E), each administered for 1 week, in 2 different treatment periods (Treatment Period 1
      and Treatment Period 2).

      In each treatment period, subjects will receive a target dose of 5 mg donepezil/day for 7
      days. There will be a washout period of 35 days between removal of the first TDS in Treatment
      Period 1 and application of the second TDS in Treatment Period 2.

      Blood samples for donepezil PK will be collected pre-dose and through to Week 6 of each
      treatment period.

      Safety will be monitored throughout the sub-study by repeated clinical, skin irritation and
      laboratory evaluations.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open Label
measure: Steady-state PK
time frame: TDS PK sampling time-points: Predose; Day 1 (hr0); Post-dose; Day 1 (hr2,6,12); Day 2-15,22 (hr0); Day 29 (hr0,3,6,12); Day 30-35 (hr0,12) Day 36 (hr0, 2,6,12); Day 37-38,41,44,47,50,54 (hr0);
description: To evaluate the steady-state PK of donepezil following once weekly Corplex Donepezil TDS application compared to once-daily (QD) oral administration of Aricept.
Aricept PK sampling time points; Day 1 (hr0,1,2,3,4,6,8,12); Day 2,8,15,22,29 (hr0); Day 35(hr0,1,2,3,4,6,8,12); Day 36-37,40,43,46,49,53 (hr0)
measure: PK (Part B)
time frame: TDS PK sampling time-points: Predose; Day 1 (hr0); Post-dose; Day 1 (hr2,6,12); Day 2-8 (hr0,12); Day 9,10,11,13,16,19,22,26,30,36 (hr0)
description: To compare the PK of 2 once-weekly Corplex Donepezil TDS treatments (target dose 5 mg donepezil/day)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (Part A and B)
time frame: Daily during 36-day confinement period and 7 visits over the 21 day wash-out period.
description: General Safety (AE and SAE as reported by subject following guidance CTCAE v4.0)
measure: PI assessment of local skin irritation response to TDS (Part A and B)
time frame: Part A: Daily during 36-day confinement period and 7 visits over the 21 day wash-out period. Part B:Daily during 10-day confinement period and 8 visits over the 28-35 day wash-out period.
description: To evaluate the safety and tolerability (including local skin irritation) of once-weekly Corplex Donepezil TDS. Skin irritation assessed using 8 pt categorical scale based on former FDA.gov/ohrms/dockets/98fr/990236GD.pdf. The Skin Irritation scale is: no irritation; minimal erythema/barely perceptible; definite erythema readily visible, minimal edema or minimal papular response; erythema and papules; definite edema; erythema, edema and papules; vesicular eruption; strong reaction spreading beyond application site.
measure: PI assessment of TDS Adhesion per FDA UCM504157
time frame: Twice daily during 36-day confinement period
description: To evaluate the adhesion of once-weekly Corplex Donepezil TDS. Adhesion is based on the adhered area (%) of the patch according to FDA.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/UCM504157.pdf. Specifically: ≥ 90% adhered (essentially no lift off skin); ≥ 75% to <90% adhered (some edges only lifting off skin); ≥ 50% to <75% adhered (less than half the TDS lifting off skin); < 50% adhered but did not detach (not detached, but more than half of the TDS lifting off skin without falling off); patch completely detached (TDS detached, completely off skin).
arm group label: Donepezil TDS Version A
arm group type: Experimental
description: Lead-in of 5 mg/day donepezil of target dose (1 x Corplex 5 mg donepezil transdermal delivery system; 7 days) followed by; Target dose of 10 mg/day donepezil (Treatment A); Corplex 10 mg donepezil transdermal delivery system.
1x patch will be worn for 7 days. A total of 4 TDS patches will be applied for 4 consecutive 7 day periods.
arm group label: Donepezil TDS Version B
arm group type: Experimental
description: Lead-in of 5 mg/day donepezil of target dose (1 x Corplex 5 mg donepezil transdermal delivery system; 7 days) followed by; Target dose of 10 mg/day donepezil (Treatment B); Corplex 10 mg donepezil delivery transdermal system.
1x patch will be worn for 7 days. A total of 4 TDS patches will be applied for 4 consecutive 7 day periods.
arm group label: 10 mg Aricept
arm group type: Active Comparator
description: 5 mg/day oral Aricept, once daily for 7 days followed by; 10 mg/day Aricept once daily for 28 days
arm group label: Donepezil TDS Version D
arm group type: Experimental
description: Target dose of 5 mg/day donepezil (Treatment D) Corplex 5 mg Donepezil TDS applied for a duration of 1 week.
arm group label: Donepezil TDS Version E
arm group type: Experimental
description: Target dose of 5 mg/day donepezil (Treatment E) Corplex 5 mg Donepezil TDS applied for a duration of 1 week
intervention type: Drug
intervention name: Donepezil TDS Version A
description: Donepezil Hydrochloride Transdermal Delivery System (5mg and 10 mg Version B)
arm group label: 10 mg Aricept
arm group label: Donepezil TDS Version B
intervention type: Drug
intervention name: Donepezil TDS Version B
description: Donepezil Hydrochloride Transdermal Delivery System (5 mg and 10 mg Version B)
arm group label: 10 mg Aricept
arm group label: Donepezil TDS Version A
intervention type: Drug
intervention name: Aricept
description: Aricept (5 mg and 10 mg) Donepezil Hydrochloride
arm group label: Donepezil TDS Version A
arm group label: Donepezil TDS Version B
other name: Aricept Tablet
intervention type: Drug
intervention name: Donepezil TDS Version D
description: Donepezil Hydrochloride Transdermal Delivery System (5 mg Version D)
arm group label: Donepezil TDS Version D
arm group label: Donepezil TDS Version E
intervention type: Drug
intervention name: Donepezil TDS Version E
description: Donepezil Hydrochloride Transdermal Delivery System (5 mg Version E)
arm group label: Donepezil TDS Version D
arm group label: Donepezil TDS Version E
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Danielle Armas, MD
role: Principal Investigator
affiliation: Celerion
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Donepezil
sharing ipd: No
ipd description: No Plans