A Study to Evaluate the Food Effect on the Pharmacokinetics of DA-5223 in Healthy Adult Subjects
NCT ID: NCT07007520
Last Updated: 2025-08-19
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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RECRUITING
PHASE1
38 participants
INTERVENTIONAL
2025-11-30
2025-11-30
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
SCREENING
NONE
Study Groups
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Sequence A
DA-5223(Fasting)
once a day
DA-5223(Fed)
once a day
Sequence B
DA-5223(Fasting)
once a day
DA-5223(Fed)
once a day
Interventions
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DA-5223(Fasting)
once a day
DA-5223(Fed)
once a day
Eligibility Criteria
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Inclusion Criteria
* Male weighing 50 kg or more, female weighing 45 kg or more with a body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2
* The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate
Exclusion Criteria
* The subjects with a history of gastrointestinal disease or surgery that may affect the absorption of Investigational Product
* The subjects hypersensitive to any of the Investigational Product components or other drug components
* The subjects who have continuously consumed excessive smoking or alcohol within 6 months of screening, or who cannot stop smoking, caffeine, or alcohol intake during hospitalization
* The subjects who are pregnant or lactating
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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CHA Global Clinical Trials Center
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DA5223_FE_I
Identifier Type: -
Identifier Source: org_study_id
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