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OpenTrials
Completed

NCT Number: NCT02178124

A Phase I Clinical Study, Randomized, Single-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects.

Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects

Completed

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Key information

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 19 ㎏/㎡, less than 27 ㎏/㎡
  • 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 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

Drug

Placebo

Drug

Primary outcomes

  1. safety and tolerability evaluation

    Time frame: patch : -1d~33d, oral : -1~11d

    evaluation item

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

Secondary outcomes

  1. pharmacokinetics characteristic evaluation

    Time frame: patch: -1~25d, oral -1~11d

    cohort 1

    1d 0h (pre-dose), 4h, 8h, 12h, 24h (2d), 48h (3d), 72h (4d), 144h (7d), 216h (10d), 288h (13d, last dose start), 292h, 296h, 300h, 312h (14d), 336h (15d), 360h (16d, patch removal), 362h, 364h, 368h, 372h, 384h (17d), 408h (18d), 432h (19d), 480h (21d), 528h (23d), 576h (25d)

    cohort 2 1 period Oral Donepezil

    1d 0h (pre-dose), 0.5h, 1h, 1.5h, 2h, 3h, 4h, 8h, 12h, 24h (2d), 48h (3d), 96h (5d), 144h (7d), 192h (9d), 240h (11d)

    period 2 Donepezil Patch: same cohort1

    evaluation item : donepezil conc.

    evaluation variable patch : AUCτ,ss, Cmax,ss, t1/2β, AI (accumulation index), Cav,ss oral : AUClast, AUC0-∞, Cmax, tmax, t1/2β, CL/F

Sponsors and collaborators

Lead sponsor

Icure Pharmaceutical Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 30, 2014
Registry last updated
Mar 25, 2015

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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