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

June 27, 2014 updated by: Icure Pharmaceutical Inc.
Study of the Safety, tolerability and pharmacokinetics with single dose of donepezil patch in healthy male subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1(12.5㎠)

drug : 9 people, 43.75mg/12.5㎠

placebo : 3 people, 12.5㎠
Drug: placebo
Drug: Donepezil patch
EXPERIMENTAL: 2(25㎠)

drug : 9 people, 87.5mg/25㎠

placebo : 3 people, 25㎠
Drug: placebo
Drug: Donepezil patch
EXPERIMENTAL: 3(50㎠)

drug : 9 people, 175mg/50㎠

placebo : 3 people, 50㎠
Drug: placebo
Drug: Donepezil patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety and tolerability evaluation
Time Frame: -1d~20d

evaluation item

  1. adverse event
  2. electrocardiographie
  3. vital sign
  4. physical examination
  5. urine, blood test
  6. skin irritation
-1d~20d

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pharmacokinetics characteristic evaluation
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

evaluation item : donepezil conc.

evaluation variable

  • AUC last, AUC0-∞, Cmax, tmax, t1/2β, CL/F
1d 0h(before administration), (after administration)4h, 8h, 12h, 24h, 48h, 70h, 72h, 74h, 76h, 80h, 96h, 120h, 144h, 168h, 216h, 264h, 312h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icure Pharmaceutical Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

May 15, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (ESTIMATE)

May 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 30, 2014

Last Update Submitted That Met QC Criteria

June 27, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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