Phase 1 Clinical Trial to Evaluate the Safety, PK and PD of DA-5207 TDS in Healthy Adults
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of DA-5207 transdermal delivery system in healthy adults
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Sequence 1 Period 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg |
Drug: Aricept 5mg Tablet
1 tablet once daily
Drug: Aricept 10mg Tablet
1 tablet once daily
Drug: DA-5207 150mg
1 patch once weekly
|
Experimental: Sequence 2 Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg |
Drug: Aricept 5mg Tablet
1 tablet once daily
Drug: Aricept 10mg Tablet
1 tablet once daily
Drug: DA-5207 150mg
1 patch once weekly
|
Experimental: Sequence 3 Period 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg |
Drug: Aricept 5mg Tablet
1 tablet once daily
Drug: Aricept 10mg Tablet
1 tablet once daily
Drug: DA-5207 170mg
1 patch once weekly
|
Experimental: Sequence 4 Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg |
Drug: Aricept 5mg Tablet
1 tablet once daily
Drug: Aricept 10mg Tablet
1 tablet once daily
Drug: DA-5207 170mg
1 patch once weekly
|
Outcome Measures
Primary Outcome Measures
- AUC [29-36 days]
area under the concentration-time curve
- Css,max [0-36 days]
maximum serum concentration at steady state
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Severance Hospital Clinical Trial Center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Dong-A ST Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DA5207_AD_Ib