Healthy Subjects (HS)Phase 1NCT07912827
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
A Phase 1 study testing YHP2508A and YHR2601 in people with Healthy Subjects (HS), run by Yuhan Corporation at 2 sites in South Korea.
Trial summary
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508A and YHR2601 in healthy subjects Read more about this study
- Who is it for?
- Ages 19 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects (HS)
- What is being tested?
- YHP2508A and YHR2601
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 20 Oct 2026to 2 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 54 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 investigational products within 6 months prior to the first administration
- Those who are judged ineligible to participate in the trial by the principal investigator
- Female volunteers who are pregnant, suspected to be pregnant or breathfeeding
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
H+ Yangji Hospital
Seoul
H+YANGJI HOSPITAL, +82-70-4665-9490, juspa@newyjh.com
- Recruiting
H+ Yangji Hospital
Seoul
H+YANGJI HOSPITAL, +82-70-4665-9519, hplus.us@gmail.com
SEUNG-HYUN KANG, MD
About this study
Official title: An Open-lable, Randomized, Fasting, Single-dose, Oral Administration, 2-sequence, 4-period, Replicate Crossover Study to Evaluate Bioequivalence Between YHP2508A and YHR2601 in Healthy Subjects
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508A and YHR2601 in healthy subjects
Read the detailed description
44 healthy subjects wiil be randomized to one of 2 groups in the same ration.
Subjects in group 1 will be administered "YHR2601" and "YHP2508A" by crossover design on periods 1 to 4.
Subjects in group 2 will be administered "YHP2508A" and "YHR2601" by crossover design on periods 1 to 4.
- Conditions
- Healthy Subjects (HS)
- Being tested
- YHP2508A, YHR2601
- Keywords
- Pharmacokinetics, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YHP2508ADrug
Test Drug
YHR2601Drug
Comparator drug
| Study group | Role | What they receive |
|---|---|---|
| A(RTRT) | Experimental | 22 subjects, Cross-over, Single dose YHR2601 on period 1 and 3, Single dose of YHP2508A on period 2 and 4. Receives: Drug: YHP2508A; Drug: YHR2601 |
| B(TRTR) | Experimental | 22 subjects, Cross-over, Single dose YHP2508A on period 1 and 3, Single dose of YHR2601 on period 2 and 4. Receives: Drug: YHP2508A; Drug: YHR2601 |
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 Amlodipine, Telmisartan \& Chlorthalidone
Measured: 0-72 hours
Maximum plasma concentration [Cmax]
Maximum plasma concentration [Cmax] of Amlodipine, Telmisartan \& Chlorthalidone
Measured: 0-72 hours
Secondary outcomes (4)
Area under the plasma drug concentration-time curve from 0 to infinity [AUCinf]
Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Amlodipine, Telmisartan \& Chlothalidone
Measured: 0-72 hours
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from 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 Amlodipine, Telmisartan \& Chlorthalidone
Measured: 0-72 hours
Time of peak concentration [Tmax]
Time of peak concentration [Tmax] of Amlodipine, Telmisartan \& Chlorthalidone
Measured: 0-72 hours
Terminal phase of half-life [t1/2]
Terminal phase of half-life [t1/2] of Amlodipine, Telmisartan \& Chlorthalidone
Measured: 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 posted3 Nov 2026
- Study start20 Oct 2026
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects (HS)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912827
- Sponsor's protocol ID
- YHP2508-103
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-lable, Randomized, Fasting, Single-dose, Oral Administration, 2-sequence, 4-period, Replicate Crossover Study to Evaluate Bioequivalence Between YHP2508A and YHR2601 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07912827
- Acronym / sponsor ID
- YHP2508-103
- Conditions
- Healthy Subjects (HS)
- Keywords
- Pharmacokinetics, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 3 Nov 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.
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508A and YHR2601 in healthy subjects
Detailed description
44 healthy subjects wiil be randomized to one of 2 groups in the same ration.
Subjects in group 1 will be administered "YHR2601" and "YHP2508A" by crossover design on periods 1 to 4.
Subjects in group 2 will be administered "YHP2508A" and "YHR2601" by crossover design on periods 1 to 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A(RTRT) | Experimental | Drug: YHP2508A, Drug: YHR260122 subjects, Cross-over, Single dose YHR2601 on period 1 and 3, Single dose of YHP2508A on period 2 and 4. |
| B(TRTR) | Experimental | Drug: YHP2508A, Drug: YHR260122 subjects, Cross-over, Single dose YHP2508A on period 1 and 3, Single dose of YHR2601 on period 2 and 4. |
Who may qualify
- Ages
- 19 to 54 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 investigational products within 6 months prior to the first administration
- Those who are judged ineligible to participate in the trial by the principal investigator
- Female volunteers who are pregnant, suspected to be pregnant or breathfeeding
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 |
|---|---|---|
| YHP2508ATest Drug | Drug | A(RTRT), B(TRTR) |
| YHR2601Comparator drug | Drug | A(RTRT), B(TRTR) |
Primary outcome
Area under the plasma drug concentration-time curve [AUCt]
Time frame: 0-72 hours
Area under the plasma drug concentration-time curve [AUCt] of Amlodipine, Telmisartan \& Chlorthalidone
Maximum plasma concentration [Cmax]
Time frame: 0-72 hours
Maximum plasma concentration [Cmax] of Amlodipine, Telmisartan \& Chlorthalidone
4 secondary outcomes
Area under the plasma drug concentration-time curve from 0 to infinity [AUCinf]
Time frame: 0-72 hours
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from 0 to infinity [AUCt/AUCinf]
Time frame: 0-72 hours
Time of peak concentration [Tmax]
Time frame: 0-72 hours
Terminal phase of half-life [t1/2]
Time frame: 0-72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YHP2508A and YHR2601 in people with Healthy Subjects (HS), run by Yuhan Corporation at 2 sites 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jungwook Lee, MS (82-2-828-0504, clinicaltrials@yuhan.co.kr), or a site near the patient. 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: 0-72 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 3 Nov 2026.