Healthy SubjectPhase 1NCT06920719
Bioequivalence Study betweenYHP2406 and YHR2501 in Healthy Subjects
A Phase 1 study testing YHP2406 and YHR2501 in people with Healthy Subject, 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 YHP2406 and YHR2501 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 Subject
- What is being tested?
- YHP2406 and YHR2501
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jun 2025to 9 Jul 2025
- 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
- BMI 18-30 kg/m2
- Those without clinically significant congenital or chronic diseases
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, Fasting, Single-dose, Oral Administration, 2- Sequence, 2-period, Crossover Study to Evaluate Bioequivalence Study Between YHP2406 and YHR2501 in Healthy Subjects
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2406 and YHR2501 in healthy volunteers
Read the 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 group 2 will be administered "YHP2406" and "comparator" by crossover design on period 1, 2.
- Conditions
- Healthy Subject
- Being tested
- YHP2406, YHR2501
- Keywords
- Pharmacokinetics, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHP2406Drug
Test drug: YHP2406, Comparator: YHR2501
YHR2501Drug
Test drug: YHP2406, Comparator: YHR2501
| Study group | Role | What they receive |
|---|---|---|
| A(RT) | Experimental | 32 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2 Receives: Drug: YHP2406; Drug: YHR2501 |
| B(TR) | Experimental | 32 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2 Receives: Drug: YHP2406; Drug: YHR2501 |
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 Amoxicillin \& Clavulanic acid
Measured: 0-8 hours
Maximum plasma concentration [Cmax]
Maximum plasma concentration [Cmax] of Amoxicillin \& Clavulanic acid
Measured: 0-8 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 Amoxicillin \& Clavulanic acid
Measured: 0-8 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 Amoxicillin \& Clavulanic acid
Measured: 0-8 Hours
Time of peak concentration [Tmax]
Time of peak concentration [Tmax] of Amoxicillin \& Clavulanic acid of Amoxicillin \& Clavulanic acid
Measured: 0-8 Hours
Terminal phase of half-life [t1/2]
Terminal phase of half-life [t1/2]
Measured: 0-8 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start29 Jun 2025
- Primary completion1 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies 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
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seoung Hyun Kang, Principal investigator, H Plus Yangji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920719
- Sponsor's protocol ID
- YHP2406-101
- Status last verified
- Jul 2025
- First submitted
- 27 Mar 2025
- Last updated
- 24 Jul 2025
- 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasting, Single-dose, Oral Administration, 2- Sequence, 2-period, Crossover Study to Evaluate Bioequivalence Study Between YHP2406 and YHR2501 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06920719
- Acronym / sponsor ID
- YHP2406-101
- Conditions
- Healthy Subject
- Keywords
- Pharmacokinetics, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 10 Apr 2025 (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 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 group 2 will be administered "YHP2406" and "comparator" by crossover design on period 1, 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A(RT) | Experimental | Drug: YHP2406, Drug: YHR250132 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2 |
| B(TR) | Experimental | Drug: YHP2406, Drug: YHR250132 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 18-30 kg/m2
- Those without clinically significant congenital or chronic diseases
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 |
|---|---|---|
| YHP2406Test drug: YHP2406, Comparator: YHR2501 | Drug | A(RT), B(TR) |
| YHR2501Test drug: YHP2406, Comparator: YHR2501 | Drug | A(RT), B(TR) |
Primary outcome
Area under the plasma drug concentration-time curve [AUCt]
Time frame: 0-8 hours
Area under the plasma drug concentration-time curve [AUCt] of Amoxicillin \& Clavulanic acid
Maximum plasma concentration [Cmax]
Time frame: 0-8 hours
Maximum plasma concentration [Cmax] of Amoxicillin \& Clavulanic acid
4 secondary outcomes
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
Time frame: 0-8 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: 0-8 Hours
Time of peak concentration [Tmax]
Time frame: 0-8 Hours
Terminal phase of half-life [t1/2]
Time frame: 0-8 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 24 Jul 2025.
- 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.
Seoung Hyun Kang principal investigator
H Plus Yangji 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 YHP2406 and YHR2501 in people with Healthy Subject, 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 2 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 24 Jul 2025. 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: 0-8 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 24 Jul 2025.