Phase 1 Clinical Trial to Evaluate the Safety, PK and PD of DA-5207 TDS in Healthy Adults
Phase 1
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT04479865
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 49
Inclusion Criteria
- Health Voulunterrs (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
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 DA-5207 150mg Period 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg Sequence 2 Aricept 10mg Tablet Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg Sequence 3 Aricept 10mg Tablet Period 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg Sequence 2 DA-5207 150mg Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg Sequence 3 Aricept 5mg Tablet Period 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg Sequence 3 DA-5207 170mg Period 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg Sequence 4 Aricept 5mg Tablet Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg Sequence 4 Aricept 10mg Tablet Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg Sequence 4 DA-5207 170mg Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg Sequence 1 Aricept 5mg Tablet Period 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg Sequence 1 Aricept 10mg Tablet Period 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg Sequence 2 Aricept 5mg Tablet Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg
- Primary Outcome Measures
Name Time Method AUC 29-36 days area under the concentration-time curve
Css,max 0-36 days maximum serum concentration at steady state
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Severance Hospital Clinical Trial Center
🇰🇷Seoul, Korea, Republic of