A Study to Evaluate the Pharmacokinetics and Safety of Diluted vs. Undiluted Intravenous DA-5217 in Healthy Adult Subjects
NCT ID: NCT07027982
Last Updated: 2025-08-22
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
32 participants
INTERVENTIONAL
2025-07-16
2025-08-14
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 1
Diluted Intravenous DA-5217
once a day
Undiluted Intravenous DA-5217
once a day
Sequence 2
Diluted Intravenous DA-5217
once a day
Undiluted Intravenous DA-5217
once a day
Interventions
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Diluted Intravenous DA-5217
once a day
Undiluted Intravenous DA-5217
once a day
Eligibility Criteria
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Inclusion Criteria
* Weighing 50 kg or more, with a body mass index (BMI) of 18.5 kg/m2 to 29.9kg/m2
* The subjects signed and dated informed consent form after hearing a detailed explanation of the study, fully understanding and determined voluntarily to participate and complied with the precautions.
Exclusion Criteria
* The subjects hypersensitive to any of the Investigational Product components or other drug components
* The subjects with clinically significant active chronic conditions
* The subjects with a positive urine drug test result or a history of drug abuse or dependence.
* The subjects who are pregnant or lactating
19 Years
45 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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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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DA5217_UGIB_I
Identifier Type: -
Identifier Source: org_study_id
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