Healthy VolunteersPhase 1NCT06665425
PK,PD and DDI of Epaminurad and C2406 in Healthy Volunteers
A Phase 1 study testing Epaminurad 9 mg and C2406 in people with Healthy Volunteers, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and C2406 in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Epaminurad 9 mg and C2406
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Mar 2025to 4 Sep 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 19~50
- Weight: between 50.0 kg~90.0 kg, Body Mass Index(BMI): 18.0 kg/m^2 or heavier and below 30.0 kg/m^2
Who cannot join
- Medical history- chronic liver disease, acute gout attack, uric acid stone, diabetes, hypertension, hyperlipidemia or lipid abnormality
- Clinical examination
- eGFR (CKD-EPI) < 90mL/min/1.73m^2
- Serum uric acid < 3 mg/dL or > 7 mg/dL
- AST (SGOT), ALT (SGPT) > upper limit of normal ranges X 1.5
- Total bilirubin, γ-GTP > upper limit of normal ranges X 1.5
- CK > upper limit of normal ranges X 2
- Positive serologic results
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trials Center
Seoul, Seoul, 110-744
About this study
Official title: An Open-label, Crossover, Phase 1 Clinical Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Drug-drug Interactions and Safety/Tolerability of Epaminurad and C2406 When Co-administered in Healthy Adults
A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and C2406 in Healthy Volunteers
- Conditions
- Healthy Volunteers
- Being tested
- Epaminurad 9 mg, C2406
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epaminurad 9 mgDrug
Period 1: Epaminurad / Period 2: C2406 -> Epaminurad + C2406
C2406Drug
Period 1: Epaminurad / Period 2: C2406 -> Epaminurad + C2406
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Epaminurad 9mg, C2406 0.6mg Receives: Drug: Epaminurad 9 mg; Drug: C2406 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)
To evaluate the AUC of Epaminurad and C2406
Measured: 7 days
Peak plasma concentrations (Cmax)
To evaluate the Cmax of Epaminurad and C2406
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start24 Mar 2025
- Primary completion2 May 2025
- Study completion4 Sep 2025
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-sang Yu, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665425
- Sponsor's protocol ID
- JW24103
- Status last verified
- Apr 2026
- First submitted
- 28 Oct 2024
- Last updated
- 20 Apr 2026
- Results posted
- 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 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Crossover, Phase 1 Clinical Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Drug-drug Interactions and Safety/Tolerability of Epaminurad and C2406 When Co-administered in Healthy Adults
- ClinicalTrials.gov ID
- NCT06665425
- Acronym / sponsor ID
- JW24103
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 30 Oct 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 Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and C2406 in Healthy Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Epaminurad 9 mg, Drug: C2406Epaminurad 9mg, C2406 0.6mg |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 19~50
- Weight: between 50.0 kg~90.0 kg, Body Mass Index(BMI): 18.0 kg/m^2 or heavier and below 30.0 kg/m^2
Key exclusion criteria (8 listed)
- Medical history- chronic liver disease, acute gout attack, uric acid stone, diabetes, hypertension, hyperlipidemia or lipid abnormality
- Clinical examination
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 |
|---|---|---|
| Epaminurad 9 mgPeriod 1: Epaminurad / Period 2: C2406 -> Epaminurad + C2406 | Drug | Arm 1 |
| C2406Period 1: Epaminurad / Period 2: C2406 -> Epaminurad + C2406 | Drug | Arm 1 |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: 7 days
To evaluate the AUC of Epaminurad and C2406
Peak plasma concentrations (Cmax)
Time frame: 7 days
To evaluate the Cmax of Epaminurad and C2406
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 20 Apr 2026.
- 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.
Kyung-sang Yu, MD principal investigator
Seoul National University 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 Epaminurad 9 mg and C2406 in people with Healthy Volunteers, run by JW Pharmaceutical 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 8 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 20 Apr 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 concentration versus time curve (AUC) (time frame: 7 days). 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 20 Apr 2026.