Phase 1 Clinical Trial to Evaluate the Safety, PK and PD of DA-5207 TDS in Healthy Adults
NCT ID: NCT04479865
Last Updated: 2021-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
49 participants
INTERVENTIONAL
2020-07-28
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence 1
Period 1, Aricept 5mg → DA-5207 150mg; Period 2, Aricept 5mg → Aricept 10mg
Aricept 5mg Tablet
1 tablet once daily
Aricept 10mg Tablet
1 tablet once daily
DA-5207 150mg
1 patch once weekly
Sequence 2
Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 150mg
Aricept 5mg Tablet
1 tablet once daily
Aricept 10mg Tablet
1 tablet once daily
DA-5207 150mg
1 patch once weekly
Sequence 3
Period 1, Aricept 5mg → DA-5207 170mg; Period 2, Aricept 5mg → Aricept 10mg
Aricept 5mg Tablet
1 tablet once daily
Aricept 10mg Tablet
1 tablet once daily
DA-5207 170mg
1 patch once weekly
Sequence 4
Period 1, Aricept 5mg → Aricept 10mg; Period 2, Aricept 5mg →DA-5207 170mg
Aricept 5mg Tablet
1 tablet once daily
Aricept 10mg Tablet
1 tablet once daily
DA-5207 170mg
1 patch once weekly
Interventions
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Aricept 5mg Tablet
1 tablet once daily
Aricept 10mg Tablet
1 tablet once daily
DA-5207 150mg
1 patch once weekly
DA-5207 170mg
1 patch once weekly
Eligibility Criteria
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Inclusion Criteria
* Body Weight : Male≥55kg, Female≥50kg
* 18.5 ≤BMI≤ 25.0
Exclusion Criteria
* 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
19 Years
55 Years
ALL
Yes
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Severance Hospital Clinical Trial Center
Seoul, , South Korea
Countries
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Other Identifiers
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DA5207_AD_Ib
Identifier Type: -
Identifier Source: org_study_id
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