Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects
NCT ID: NCT06920719
Last Updated: 2025-07-24
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
64 participants
INTERVENTIONAL
2025-06-29
2025-07-09
Brief Summary
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Detailed Description
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Subjects in group 1 will be administered "comparator" and "YHP2406" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2406" and "comparator" by crossover design on period 1, 2.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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A(RT)
32 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2
YHP2406
Test drug: YHP2406, Comparator: YHR2501
YHR2501
Test drug: YHP2406, Comparator: YHR2501
B(TR)
32 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2
YHP2406
Test drug: YHP2406, Comparator: YHR2501
YHR2501
Test drug: YHP2406, Comparator: YHR2501
Interventions
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YHP2406
Test drug: YHP2406, Comparator: YHR2501
YHR2501
Test drug: YHP2406, Comparator: YHR2501
Eligibility Criteria
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Inclusion Criteria
* Those without clinically significant congenital or chronic diseases
Exclusion Criteria
* Others who are judged ineligible to participate in the trial by the principal investigator.
* Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.
19 Years
ALL
Yes
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Seoung Hyun Kang
Role: PRINCIPAL_INVESTIGATOR
H Plus Yangji Hospital
Locations
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H Plus Yangji Hospital
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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YHP2406-101
Identifier Type: -
Identifier Source: org_study_id
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