Status:
COMPLETED
Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK 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
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 a...
Eligibility Criteria
Inclusion
- Health Male Volunteers (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 :
June 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04013477
Start Date
June 18 2019
End Date
April 6 2020
Last Update
April 14 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trials Center, Severance Hospital
Seoul, South Korea, 03722