Healthy VolunteersPhase 1NCT06359626
Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers
A Phase 1 study testing YHP2205 and YHR2401 in people with Healthy Volunteers, run by Yuhan Corporation at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- YHP2205 and YHR2401
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jun 2024to 6 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2-period, Crossover Study to Evaluate Bioequivalence Between YHP2205 and YHR2401 in Healthy Subjects
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers
Read the detailed description
60 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "YHP2205" and "comparator" by cross-over design on day 1, 8
Subjects in group 2 will be administered "comparator" and "YHP2205" by cross-over design on day 1, 8.
- Conditions
- Healthy Volunteers
- Being tested
- YHP2205, YHR2401
- Keywords
- Pharmacokinetics, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHP2205Drug
Test drug: YHP2205
YHR2401Drug
comparator: YHR2401
| Study group | Role | What they receive |
|---|---|---|
| Sequence Group A | Experimental | 30 subjects, Cross-over, Single dose of YHR2401 on day 1, Single dose of YHP2205 on day 8 Receives: Drug: YHP2205; Drug: YHR2401 |
| Sequence Group B | Experimental | 30 subjects, Cross-over, Single dose of YHP2205 on day 1, Single dose of YHR2401 on day 8 Receives: Drug: YHP2205; Drug: YHR2401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma drug concentration-time curve [AUCt]
Area under the plasma drug concentration-time curve [AUCt] of Edoxaban
Measured: 0-36 hours
Maximum plasma concentration [Cmax]
Maximum plasma concentration [Cmax] of Edoxaban
Measured: 0-36 hours
Secondary outcomes (4)
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Edoxaban
Measured: 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]
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of Edoxaban
Measured: 0-36 hours
Time of peak concentration [Tmax]
Time of peak concentration [Tmax] of Edoxaban
Measured: 0-36 hours
Terminal phase of half-life [t1/2]
Terminal phase of half-life [t1/2] of Edoxaban
Measured: 0-36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start21 Jun 2024
- Primary completion30 Jun 2024
- Study completion6 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- two-way crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taegon Hong, Principal investigator, Bumin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359626
- Sponsor's protocol ID
- YHP2205-101
- Status last verified
- Nov 2024
- First submitted
- 7 Apr 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2-period, Crossover Study to Evaluate Bioequivalence Between YHP2205 and YHR2401 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06359626
- Acronym / sponsor ID
- YHP2205-101
- Conditions
- Healthy Volunteers
- Keywords
- Pharmacokinetics, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 6 Jul 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers
Detailed description
60 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "YHP2205" and "comparator" by cross-over design on day 1, 8
Subjects in group 2 will be administered "comparator" and "YHP2205" by cross-over design on day 1, 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-way crossover
| Arm | Type | Receives |
|---|---|---|
| Sequence Group A | Experimental | Drug: YHP2205, Drug: YHR240130 subjects, Cross-over, Single dose of YHR2401 on day 1, Single dose of YHP2205 on day 8 |
| Sequence Group B | Experimental | Drug: YHP2205, Drug: YHR240130 subjects, Cross-over, Single dose of YHP2205 on day 1, Single dose of YHR2401 on day 8 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YHP2205Test drug: YHP2205 | Drug | Sequence Group A, Sequence Group B |
| YHR2401comparator: YHR2401 | Drug | Sequence Group A, Sequence Group B |
Primary outcome
Area under the plasma drug concentration-time curve [AUCt]
Time frame: 0-36 hours
Area under the plasma drug concentration-time curve [AUCt] of Edoxaban
Maximum plasma concentration [Cmax]
Time frame: 0-36 hours
Maximum plasma concentration [Cmax] of Edoxaban
4 secondary outcomes
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
Time frame: 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]
Time frame: 0-36 hours
Time of peak concentration [Tmax]
Time frame: 0-36 hours
Terminal phase of half-life [t1/2]
Time frame: 0-36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taegon Hong principal investigator
Bumin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YHP2205 and YHR2401 in people with Healthy Volunteers, run by Yuhan Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma drug concentration-time curve [AUCt] (time frame: 0-36 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.