Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults
NCT ID: NCT04013477
Last Updated: 2021-04-14
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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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2019-06-18
2020-04-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cohort1
drug : DA-5207 80mg/40cm²
placebo : 40cm²
DA-5207
DA-5207 Transdermal Delivery System
Cohort2
drug : DA-5207 120mg/60cm²
placebo : 60cm²
DA-5207
DA-5207 Transdermal Delivery System
Cohort3
drug : DA-5207 160mg/80cm²
placebo : 80cm²
DA-5207
DA-5207 Transdermal Delivery System
Cohort4
drug : Aricept
Donepezil Hydrochloride
donepezil HCl 10mg QD
Interventions
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DA-5207
DA-5207 Transdermal Delivery System
Donepezil Hydrochloride
donepezil HCl 10mg QD
Other Intervention Names
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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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Clinical Trials Center, Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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DA5207_ADK_Ia
Identifier Type: -
Identifier Source: org_study_id
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