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NCT05127746 Clinical Trial

Phase 1 Clinical Trial of DA-5207 in Healthy Adults

Healthy Clinical Trial

Official title:
An Open-label, Randomized, Cross-over, Multiple Dose, Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of DA-5207 Transdermal Delivery System in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05127746
Other study ID # DA5207_AD2_Ib
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 25, 2021
Est. completion date December 13, 2022

Study information
Verified date April 2023
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date December 13, 2022
Est. primary completion date December 13, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility Inclusion Criteria: - Health 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 caffeine intake - Heavy alcohol intake (more than 210g/week) - Heavy smoker (more than 10 cigarettes/day)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Aricept 5mg Tablet
1 tablet once daily
• Aricept 10mg Tablet
1 tablet once daily
• DA-5207 A
1 patch once weekly
• DA-5207 B
1 patch once weekly

Locations
Country Name City State
Korea, Republic of Jeonbuk National University Hospital Jeonju Jeonbuk

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUC area under the concentration-time curve 29-36 days
Primary Css,max maximum serum concentration at steady state 0-36 days
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