Healthy VolunteerPhase 1NCT06926387
Bioequivalence Study betweenYHP2407 and YHR2502 in Healthy Subjects
A Phase 1 study testing YHP2407 and YHR2502 in people with Healthy Volunteer, 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 YHP2407 and YHR2502 in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- YHP2407 and YHR2502
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Apr 2025to 29 Apr 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 to 64 years
- All sexes
- Healthy volunteers accepted
- 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, Single-dose, Oral Administration, 2-sequence, 2- Period, Crossover Study to Evaluate Bioequivalence Between YHP2407 and YHR2502 in Healthy Subjects
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2407 and YHR2502 in healthy volunteers
Read the detailed description
40 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "comparator" and "YHP2407" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2407" and "comparator" by crossover design on period 1, 2.
- Conditions
- Healthy Volunteer
- Being tested
- YHP2407, YHR2502
- Keywords
- Pharmacokinetics, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHP2407Drug
Test drug: YHP2407, Comparator: YHR2502
YHR2502Drug
Test drug: YHP2407, Comparator: YHR2502
| Study group | Role | What they receive |
|---|---|---|
| A(RT) | Experimental | 20 subjects, Cross-over, Single dose YHR2502 on period
1, Single dose of YHP2407 on period 2 Receives: Drug: YHP2407; Drug: YHR2502 |
| B(TR) | Experimental | 20 subjects, Cross-over, Single dose of YHP2407 on period 1, Single dose of YHR2502 on period 2 Receives: Drug: YHP2407; Drug: YHR2502 |
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 Cefaclor Hydrate
Measured: 0-6 hours
Maximum plasma concentration [Cmax]
Maximum plasma concentration [Cmax] of Cefaclor Hydrate
Measured: 0-6 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 Cefaclor Hydrate
Measured: 0-6 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 Cefaclor Hydrate
Measured: 0-6 hours
Time of peak concentration [Tmax]
Time of peak concentration [Tmax] of Cefaclor Hydrate
Measured: 0-6 hours
Terminal phase of half-life [t1/2]
Terminal phase of half-life [t1/2] of Cefaclor Hydrate
Measured: 0-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start17 Apr 2025
- Primary completion19 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyejin Lim, Principal investigator, Gimpo Woori Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926387
- Sponsor's protocol ID
- YHP2407-101
- Status last verified
- May 2025
- First submitted
- 6 Apr 2025
- Last updated
- 13 May 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 13 May 2025. 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 YHP2407 and YHR2502 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06926387
- Acronym / sponsor ID
- YHP2407-101
- Conditions
- Healthy Volunteer
- Keywords
- Pharmacokinetics, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 19 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 13 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 YHP2407 and YHR2502 in healthy volunteers
Detailed description
40 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "comparator" and "YHP2407" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2407" 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: YHP2407, Drug: YHR250220 subjects, Cross-over, Single dose YHR2502 on period 1, Single dose of YHP2407 on period 2 |
| B(TR) | Experimental | Drug: YHP2407, Drug: YHR250220 subjects, Cross-over, Single dose of YHP2407 on period 1, Single dose of YHR2502 on period 2 |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 |
|---|---|---|
| YHP2407Test drug: YHP2407, Comparator: YHR2502 | Drug | A(RT), B(TR) |
| YHR2502Test drug: YHP2407, Comparator: YHR2502 | Drug | A(RT), B(TR) |
Primary outcome
Area under the plasma drug concentration-time curve [AUCt]
Time frame: 0-6 hours
Area under the plasma drug concentration-time curve [AUCt] of Cefaclor Hydrate
Maximum plasma concentration [Cmax]
Time frame: 0-6 hours
Maximum plasma concentration [Cmax] of Cefaclor Hydrate
4 secondary outcomes
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
Time frame: 0-6 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: 0-6 hours
Time of peak concentration [Tmax]
Time frame: 0-6 hours
Terminal phase of half-life [t1/2]
Time frame: 0-6 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 13 May 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.
Hyejin Lim principal investigator
Gimpo Woori 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 YHP2407 and YHR2502 in people with Healthy Volunteer, 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 13 May 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: 0-6 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 13 May 2025.