Phase 1 Clinical Trial of DA-5207 in Healthy Adults
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
1 other identifier
interventional
51
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Nov 2021
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedStudy Start
First participant enrolled
November 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2022
CompletedApril 14, 2023
April 1, 2023
1 year
November 5, 2021
April 12, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
AUC
area under the concentration-time curve
29-36 days
Css,max
maximum serum concentration at steady state
0-36 days
Study Arms (4)
Sequence 1
EXPERIMENTALPeriod 1, Aricept 5mg → DA-5207 A; Period 2, Aricept 5mg → Aricept 10mg
Sequence 2
EXPERIMENTALPeriod 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg → DA-5207 A
Sequence 3
EXPERIMENTALPeriod 1, Aricept 5mg → DA-5207 B; Period 2, Aricept 5mg → Aricept 10mg
Sequence 4
EXPERIMENTALPeriod 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg → DA-5207 B
Interventions
Eligibility Criteria
You may qualify if:
- Health Volunteers (Age: 19\~55 years)
- Body Weight: Male≥55kg, Female≥50kg
- ≤BMI≤ 25.0
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2021
First Posted
November 19, 2021
Study Start
November 25, 2021
Primary Completion
December 13, 2022
Study Completion
December 13, 2022
Last Updated
April 14, 2023
Record last verified: 2023-04