Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults

April 13, 2021 updated by: Dong-A ST Co., Ltd.

A Single-blinded, Placebo- and Active-controlled, Parallel, Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DA-5207 Transdermal Delivery System in Healthy Adults

A single-blinded, placebo- and active-controlled, parallel, single-ascending dose phase 1 clinical trial to evaluate the safety and pharmacokinetics of DA-5207 transdermal delivery system in healthy adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Clinical Trials Center, Severance Hospital

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

19 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Health Male Volunteers (Age : 19~55 years)
  • Body Weight : Male≥55kg, Female≥50kg
  • 18.5≤BMI<25.0

Exclusion Criteria:

  • Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
  • Allergy or Drug hypersensitivity
  • Clinically significant Medical History
  • AST, ALT > Upper Normal Range*1.25, eGFR<60mL/min/1.73m²
  • Heavy alcohol intake (more than 210g/week)
  • Heavy smoker (more than 10 cigarettes/day)
  • Heavy caffeine intake

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort1

drug : DA-5207 80mg/40cm²

placebo : 40cm²
Drug: DA-5207
DA-5207 Transdermal Delivery System
EXPERIMENTAL: Cohort2

drug : DA-5207 120mg/60cm²

placebo : 60cm²
Drug: DA-5207
DA-5207 Transdermal Delivery System
EXPERIMENTAL: Cohort3

drug : DA-5207 160mg/80cm²

placebo : 80cm²
Drug: DA-5207
DA-5207 Transdermal Delivery System
ACTIVE_COMPARATOR: Cohort4
drug : Aricept
Drug: Donepezil Hydrochloride
donepezil HCl 10mg QD
Other Names:
  • Aricept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: patch : 21days, oral : 11days
area under the concentration-time curve
patch : 21days, oral : 11days
Cmax
Time Frame: patch : 21days, oral : 11days
maximum serum concentration
patch : 21days, oral : 11days

Collaborators and Investigators

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

Sponsor

Dong-A ST Co., Ltd.

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 (ACTUAL)

June 18, 2019

Primary Completion (ACTUAL)

December 5, 2019

Study Completion (ACTUAL)

April 6, 2020

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (ACTUAL)

July 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA5207_ADK_Ia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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