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OpenTrials
Completed

NCT Number: NCT01860625

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

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

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

ASAN Medical Center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Donepezil patch

Drug

Placebo

Drug

Primary outcomes

  1. safety and tolerability evaluation

    Time frame: -1d~20d

    evaluation item

    • adverse event
    • electrocardiographie
    • vital sign
    • physical examination
    • urine, blood test
    • skin irritation

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Icure Pharmaceutical Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
May 23, 2013
Registry last updated
Jun 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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