Status:
COMPLETED
Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects
Lead Sponsor:
Yuhan Corporation
Conditions:
Healthy Subject
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2406 and YHR2501 in healthy volunteers
Detailed Description
62 healthy subjects will be randomized to one of the 2 groups in the same ratio. Subjects in group 1 will be administered "comparator" and "YHP2406" by crossover design on period 1, 2. Subjects in gr...
Eligibility Criteria
Inclusion
- BMI 18-30 kg/m2
- Those without clinically significant congenital or chronic diseases
Exclusion
- Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
- 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.
Key Trial Info
Start Date :
June 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2025
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06920719
Start Date
June 29 2025
End Date
July 9 2025
Last Update
July 24 2025
Active Locations (1)
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1
H Plus Yangji Hospital
Seoul, Seoul, South Korea, 08779