Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers
NCT ID: NCT06616883
Last Updated: 2024-09-27
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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NOT_YET_RECRUITING
PHASE1
44 participants
INTERVENTIONAL
2024-09-30
2024-11-18
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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Experimental: Sequence A
DA-5221_01
single dose administration (DA-5221\_01 one tablet once a day)
DA-5221_01-R1 + DA-5221_01-R2
single dose administration (DA-5221\_01-R1 one tablet once a day + DA-5221\_01-R2 one tablet once a day)
Experimental: Sequence B
DA-5221_01
single dose administration (DA-5221\_01 one tablet once a day)
DA-5221_01-R1 + DA-5221_01-R2
single dose administration (DA-5221\_01-R1 one tablet once a day + DA-5221\_01-R2 one tablet once a day)
Interventions
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DA-5221_01
single dose administration (DA-5221\_01 one tablet once a day)
DA-5221_01-R1 + DA-5221_01-R2
single dose administration (DA-5221\_01-R1 one tablet once a day + DA-5221\_01-R2 one tablet once a day)
Eligibility Criteria
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Inclusion Criteria
* BMI between 18 and 30 kg/m2
* Body weight: Male≥50kg, Female≥45kg
* Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study
Exclusion Criteria
* Subjects with history of drug abuse or addicted
19 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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Bumin Hospital
Seoul, South Korea, South Korea
Countries
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Central Contacts
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Facility Contacts
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TaeGon Hong, Ph.D
Role: primary
Other Identifiers
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DA5221_01_BE_I
Identifier Type: -
Identifier Source: org_study_id