Healthy SubjectsPhase 1NCT07470125
Bioequivalence (BE) Study Between YHP2511 and YHP2511A in Healthy Volunteers
A Phase 1 study testing YHP2511 and YHP2511A in people with Healthy Subjects, 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 YHP2511 and YHP2511A in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- YHP2511 and YHP2511A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2026to 20 Jul 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 19 to 55 years at the time of screening visit.
- Those whose weight is ≥ 50 kg (≥ 45 kg for females) 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, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of YHP2511 With YHP2511A in Healthy Adult Volunteers
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2511 and YHP2511A 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 "comparator" and "YHP2511" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2511" and "comparator" by crossover design on period 1, 2.
- Conditions
- Healthy Subjects
- Being tested
- YHP2511, YHP2511A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHP2511Drug
Test drug: YHP2511, Comparator: YHP2511A
YHP2511ADrug
Test drug: YHP2511, Comparator: YHP2511A
| Study group | Role | What they receive |
|---|---|---|
| A (RT) | Experimental | 30 subjects, Cross-over, Single dose YHP2511A on period 1, Single dose of YHP2511 on period 2 Receives: Drug: YHP2511; Drug: YHP2511A |
| B (TR) | Experimental | 30 subjects, Cross-over, Single dose YHP2511 on period 1, Single dose of YHP2511A on period 2 Receives: Drug: YHP2511; Drug: YHP2511A |
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 Pitavastatin \& Total Ezetimibe
Measured: Pitavastatin : 0-72 hours, Total Ezetimibe: 0-72 hours
Maximum plasma concentration [Cmax]
Maximum plasma concentration [Cmax] of - Pitavastatin \& Total Ezetimibe
Measured: Pitavastatin: 0-48 hours, Total Ezetimibe: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start23 Jun 2026
- Primary completion11 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- 61 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
- NCT07470125
- Sponsor's protocol ID
- YHP2511-101
- Status last verified
- Jul 2026
- First submitted
- 10 Mar 2026
- Last updated
- 22 Jul 2026
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Bioequivalence of YHP2511 With YHP2511A in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT07470125
- Acronym / sponsor ID
- YHP2511-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 11 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 13 Mar 2026 (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 YHP2511 and YHP2511A 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 "comparator" and "YHP2511" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2511" 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: YHP2511, Drug: YHP2511A30 subjects, Cross-over, Single dose YHP2511A on period 1, Single dose of YHP2511 on period 2 |
| B (TR) | Experimental | Drug: YHP2511, Drug: YHP2511A30 subjects, Cross-over, Single dose YHP2511 on period 1, Single dose of YHP2511A on period 2 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 19 to 55 years at the time of screening visit.
- Those whose weight is ≥ 50 kg (≥ 45 kg for females) 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 |
|---|---|---|
| YHP2511Test drug: YHP2511, Comparator: YHP2511A | Drug | A (RT), B (TR) |
| YHP2511ATest drug: YHP2511, Comparator: YHP2511A | Drug | A (RT), B (TR) |
Primary outcome
Area under the plasma drug concentration-time curve [AUCt]
Time frame: Pitavastatin : 0-72 hours, Total Ezetimibe: 0-72 hours
Area under the plasma drug concentration-time curve [AUCt] of Pitavastatin \& Total Ezetimibe
Maximum plasma concentration [Cmax]
Time frame: Pitavastatin: 0-48 hours, Total Ezetimibe: 0-72 hours
Maximum plasma concentration [Cmax] of - Pitavastatin \& Total Ezetimibe
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 22 Jul 2026.
- Individual participant dataSharing planned: No
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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 YHP2511 and YHP2511A in people with Healthy Subjects, 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 22 Jul 2026. 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: Pitavastatin : 0-72 hours, Total Ezetimibe: 0-72 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 22 Jul 2026.