Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers
An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2-period, Crossover Study to Evaluate Bioequivalence Between YHP2205 and YHR2401 in Healthy Subjects
1 other identifier
interventional
60
1 country
1
Brief Summary
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Jun 2024
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2024
CompletedFirst Posted
Study publicly available on registry
April 11, 2024
CompletedStudy Start
First participant enrolled
June 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2024
CompletedNovember 12, 2024
November 1, 2024
9 days
April 7, 2024
November 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area under the plasma drug concentration-time curve [AUCt]
Area under the plasma drug concentration-time curve \[AUCt\] of Edoxaban
0-36 hours
Maximum plasma concentration [Cmax]
Maximum plasma concentration \[Cmax\] of Edoxaban
0-36 hours
Secondary Outcomes (4)
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
0-36 hours
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
0-36 hours
Time of peak concentration [Tmax]
0-36 hours
Terminal phase of half-life [t1/2]
0-36 hours
Study Arms (2)
Sequence Group A
EXPERIMENTAL30 subjects, Cross-over, Single dose of YHR2401 on day 1, Single dose of YHP2205 on day 8
Sequence Group B
EXPERIMENTAL30 subjects, Cross-over, Single dose of YHP2205 on day 1, Single dose of YHR2401 on day 8
Interventions
Eligibility Criteria
You may qualify if:
- Those who are 19 years old or older at the screening visit
- Those whose weight is \> 60kg and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
- Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination
- Those who express their voluntary consent to participate in the trial by signing a written consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bumin Hospital
Seoul, 07590, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Taegon Hong
Bumin Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2024
First Posted
April 11, 2024
Study Start
June 21, 2024
Primary Completion
June 30, 2024
Study Completion
July 6, 2024
Last Updated
November 12, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share