Status:
UNKNOWN
Phase 1 Clinical Trial to Evaluate the Safety, PK and PD of DA-5207 TDS in Healthy Adults
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults
Eligibility Criteria
Inclusion
- Health Voulunterrs (Age : 19\~55 years)
- Body Weight : Male≥55kg, Female≥50kg
- 5 ≤BMI≤ 25.0
Exclusion
- 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
Key Trial Info
Start Date :
July 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04479865
Start Date
July 28 2020
End Date
April 30 2021
Last Update
April 15 2021
Active Locations (1)
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1
Severance Hospital Clinical Trial Center
Seoul, South Korea