Bioequivalence Study Between YHP2305 and YHR2404 in Healthy Volunteers
NCT ID: NCT06613139
Last Updated: 2024-11-15
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
34 participants
INTERVENTIONAL
2024-10-06
2024-10-24
Brief Summary
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Detailed Description
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Subjects in group B will be administered YHP2305 and comparator by crossover design on day 1, 8.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group A(RT)
17 subjects, Cross-over, Single dose of YHR2404 on day 1, Single dose of YHP2305 on day 8
YHP2305
Test drug: YHP2305 Comparator: YHR2404
YHR2404
Test drug: YHP2305 comparator: YHR2404
Group B(TR)
17 subjects, Cross-over, Single dose of YHP2305 on day 1, Single dose of YHR2404 on day 8
YHP2305
Test drug: YHP2305 Comparator: YHR2404
YHR2404
Test drug: YHP2305 comparator: YHR2404
Interventions
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YHP2305
Test drug: YHP2305 Comparator: YHR2404
YHR2404
Test drug: YHP2305 comparator: YHR2404
Eligibility Criteria
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Inclusion Criteria
* Those whose weight is over 50kg(male), over 45kg(female) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
* Those who express their voluntary consent to participate in the trial by signing a written consent
* Those who are judged eligible to participate in the trial by the principal investigator(or delegated investigators) after screening test
Exclusion Criteria
* Others who are judged ineligible to participate in the trial by the principal investigator.
19 Years
ALL
Yes
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Taegon Hong
Role: PRINCIPAL_INVESTIGATOR
Locations
Locations
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Bumin Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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YHP2305-101
Identifier Type: -
Identifier Source: org_study_id
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