Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults
- Registration Number
- NCT04013477
- Lead Sponsor
- Dong-A ST Co., Ltd.
- 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 adults
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Health Male 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 alcohol intake (more than 210g/week)
- Heavy smoker (more than 10 cigarettes/day)
- Heavy caffeine intake
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort1 DA-5207 drug : DA-5207 80mg/40cm² placebo : 40cm² Cohort3 DA-5207 drug : DA-5207 160mg/80cm² placebo : 80cm² Cohort2 DA-5207 drug : DA-5207 120mg/60cm² placebo : 60cm² Cohort4 Donepezil Hydrochloride drug : Aricept
- Primary Outcome Measures
Name Time Method Cmax patch : 21days, oral : 11days maximum serum concentration
AUC patch : 21days, oral : 11days area under the concentration-time curve
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Trials Center, Severance Hospital
🇰🇷Seoul, Korea, Republic of
Clinical Trials Center, Severance Hospital🇰🇷Seoul, Korea, Republic of