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A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Donepezil patch
placebo
Sponsored by
Icure Pharmaceutical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI : more than 20 ㎏/㎡, less than 26 ㎏/㎡
  • Systolic blood pressure : more than 90, less than 140 (mmHg)
  • Diastolic blood pressure : more than 60, less than 100 (mmHg)

Exclusion Criteria:

  • Evidence of clinically significant, severe, active, or unstable gastrointestinal, renal,hepatic, respiratory, hematological, endocrine, or cardiovascular system disease.
  • A history of skin disease or skin graft
  • Hypersensitivity to donepezil or piperidine derivatives or any of the excipients.
  • A known or suspected history of drug or alcohol dependency or abuse
  • Patients who have participated in another clinical study within 60 days.
  • Whole blood within 60 days, apheresis within 30 days, transfusion within 30 days
  • Heavy caffeine intake(more than 5 units/day)
  • Heavy alcohol intake(more than 21 units/week)
  • Heavy smoker(more than 10 cigarette/day)
  • Abnormal clinical laboratory values which are judged clinically significant by the investigator.
  • Any condition that would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study.

Sites / Locations

  • ASAN Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1(12.5㎠)

2(25㎠)

3(50㎠)

Arm Description

drug : 9 people, 43.75mg/12.5㎠ placebo : 3 people, 12.5㎠

drug : 9 people, 87.5mg/25㎠ placebo : 3 people, 25㎠

drug : 9 people, 175mg/50㎠ placebo : 3 people, 50㎠

Outcomes

Primary Outcome Measures

safety and tolerability evaluation
evaluation item adverse event electrocardiographie vital sign physical examination urine, blood test skin irritation

Secondary Outcome Measures

pharmacokinetics characteristic evaluation
evaluation item : donepezil conc. evaluation variable AUC last, AUC0-∞, Cmax, tmax, t1/2β, CL/F

Full Information

First Posted
May 15, 2013
Last Updated
June 27, 2014
Sponsor
Icure Pharmaceutical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01860625
Brief Title
A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icure Pharmaceutical Inc.

4. Oversight

5. Study Description

Brief Summary
Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in healthy male subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1(12.5㎠)
Arm Type
Experimental
Arm Description
drug : 9 people, 43.75mg/12.5㎠ placebo : 3 people, 12.5㎠
Arm Title
2(25㎠)
Arm Type
Experimental
Arm Description
drug : 9 people, 87.5mg/25㎠ placebo : 3 people, 25㎠
Arm Title
3(50㎠)
Arm Type
Experimental
Arm Description
drug : 9 people, 175mg/50㎠ placebo : 3 people, 50㎠
Intervention Type
Drug
Intervention Name(s)
Donepezil patch
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
safety and tolerability evaluation
Description
evaluation item adverse event electrocardiographie vital sign physical examination urine, blood test skin irritation
Time Frame
-1d~20d
Secondary Outcome Measure Information:
Title
pharmacokinetics characteristic evaluation
Description
evaluation item : donepezil conc. evaluation variable AUC last, AUC0-∞, Cmax, tmax, t1/2β, CL/F
Time Frame
1d 0h(before administration), (after administration)4h, 8h, 12h, 24h, 48h, 70h, 72h, 74h, 76h, 80h, 96h, 120h, 144h, 168h, 216h, 264h, 312h

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI : more than 20 ㎏/㎡, less than 26 ㎏/㎡ Systolic blood pressure : more than 90, less than 140 (mmHg) Diastolic blood pressure : more than 60, less than 100 (mmHg) Exclusion Criteria: Evidence of clinically significant, severe, active, or unstable gastrointestinal, renal,hepatic, respiratory, hematological, endocrine, or cardiovascular system disease. A history of skin disease or skin graft Hypersensitivity to donepezil or piperidine derivatives or any of the excipients. A known or suspected history of drug or alcohol dependency or abuse Patients who have participated in another clinical study within 60 days. Whole blood within 60 days, apheresis within 30 days, transfusion within 30 days Heavy caffeine intake(more than 5 units/day) Heavy alcohol intake(more than 21 units/week) Heavy smoker(more than 10 cigarette/day) Abnormal clinical laboratory values which are judged clinically significant by the investigator. Any condition that would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study.
Facility Information:
Facility Name
ASAN Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26014587
Citation
Choi HY, Kim YH, Hong D, Kim SS, Bae KS, Lim HS. Therapeutic dosage assessment based on population pharmacokinetics of a novel single-dose transdermal donepezil patch in healthy volunteers. Eur J Clin Pharmacol. 2015 Aug;71(8):967-77. doi: 10.1007/s00228-015-1875-2. Epub 2015 May 28.
Results Reference
derived

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A Phase I Clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects

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