Phase 1 Clinical Trial to Evaluate the Safety, PK and PD of DA-5207 TDS 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
49
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 Jul 2020
Typical duration 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2020
CompletedFirst Posted
Study publicly available on registry
July 21, 2020
CompletedStudy Start
First participant enrolled
July 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedApril 15, 2021
April 1, 2021
4 months
July 12, 2020
April 13, 2021
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 150mg; Period 2, Aricept 5mg → Aricept 10mg
Sequence 2
EXPERIMENTALPeriod 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg
Sequence 3
EXPERIMENTALPeriod 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg
Sequence 4
EXPERIMENTALPeriod 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg
Interventions
Eligibility Criteria
You may qualify if:
- Health Voulunterrs (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 alcohol intake (more than 210g/week)
- Heavy smoker (more than 10 cigarettes/day)
- Heavy caffeine intake
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital Clinical Trial Center
Seoul, 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
July 12, 2020
First Posted
July 21, 2020
Study Start
July 28, 2020
Primary Completion
December 9, 2020
Study Completion
April 30, 2021
Last Updated
April 15, 2021
Record last verified: 2021-04