HealthyPhase 1NCT07374406
To Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers
A Phase 1 study testing Epaminurad 9 mg (JW Pharmaceutical) and Epaminurad 9 mg (Shanghai STA Pharmaceutical) in people with Healthy, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
A randomized, open-label, single dose, 2x2 crossover study to evaluate the safety and pharmacokinetic characteristics after administration of Epaminurad in healthy adult volunteers under fasting conditions Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Epaminurad 9 mg (JW Pharmaceutical) and Epaminurad 9 mg (Shanghai STA Pharmaceutical)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Feb 2026to 24 Feb 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
- Age: 19~55
- Weight: at least 50 kg for males and 45 kg for females. 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) < 60mL/min/1.73m^2, AST (SGOT), ALT (SGPT) > upper limit of normal ranges X 2, CK > upper limit of normal ranges X 5, Positive serologic results Cystatin C > 1.26mg/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, 2x2 Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Epaminurad in Healthy Adult Volunteers Under Fasting Conditions
A randomized, open-label, single dose, 2x2 crossover study to evaluate the safety and pharmacokinetic characteristics after administration of Epaminurad in healthy adult volunteers under fasting conditions
- Conditions
- Healthy
- Being tested
- Epaminurad 9 mg (JW Pharmaceutical), Epaminurad 9 mg (Shanghai STA Pharmaceutical)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epaminurad 9 mg (JW Pharmaceutical)Drug
Test product. A single oral dose of 1 tablet containing 9 mg of Epaminurad.
Epaminurad 9 mg (Shanghai STA Pharmaceutical)Drug
Reference product. A single oral dose of 1 tablet containing 9 mg of Epaminurad.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Subjects receive a single dose of Treatment A (JW Pharmaceutical) in Period 1, followed by a washout period, and then a single dose of Treatment B (Shanghai STA Pharmaceutical) in Period 2. Receives: Drug: Epaminurad 9 mg (JW Pharmaceutical); Drug: Epaminurad 9 mg (Shanghai STA Pharmaceutical) |
| Group 2 | Experimental | Subjects receive a single dose of Treatment B (Shanghai STA Pharmaceutical) in Period 1, followed by a washout period, and then a single dose of Treatment A (JW Pharmaceutical) in Period 2. Receives: Drug: Epaminurad 9 mg (JW Pharmaceutical); Drug: Epaminurad 9 mg (Shanghai STA Pharmaceutical) |
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
Measured: 3 days
Peak plasma concentrations (Cmax)
To evaluate the Cmax of Epaminurad
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start2 Feb 2026
- Primary completion19 Feb 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, open-label, single dose, 2x2 crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seol Ju Moon, Principal investigator, Jeonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374406
- Sponsor's protocol ID
- JW25103
- Status last verified
- Aug 2026
- First submitted
- 1 Jan 2026
- Last updated
- 13 Aug 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, 2x2 Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Epaminurad in Healthy Adult Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT07374406
- Acronym / sponsor ID
- JW25103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 28 Jan 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, 2x2 crossover study to evaluate the safety and pharmacokinetic characteristics after administration of Epaminurad in healthy adult volunteers under fasting conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, open-label, single dose, 2x2 crossover
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Epaminurad 9 mg (JW Pharmaceutical), Drug: Epaminurad 9 mg (Shanghai STA Pharmaceutical)Subjects receive a single dose of Treatment A (JW Pharmaceutical) in Period 1, followed by a washout period, and then a single dose of Treatment B (Shanghai STA Pharmaceutical) in Period 2. |
| Group 2 | Experimental | Drug: Epaminurad 9 mg (JW Pharmaceutical), Drug: Epaminurad 9 mg (Shanghai STA Pharmaceutical)Subjects receive a single dose of Treatment B (Shanghai STA Pharmaceutical) in Period 1, followed by a washout period, and then a single dose of Treatment A (JW Pharmaceutical) in Period 2. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 19~55
- Weight: at least 50 kg for males and 45 kg for females. Body Mass Index(BMI): 18.0 kg/m^2 or heavier and below 30.0 kg/m^2
Key exclusion criteria (2 listed)
- Medical history- chronic liver disease, acute gout attack, uric acid stone, diabetes, hypertension, hyperlipidemia or lipid abnormality
- Clinical examination- eGFR (CKD-EPI) < 60mL/min/1.73m^2, AST (SGOT), ALT (SGPT) > upper limit of normal ranges X 2, CK > upper limit of normal ranges X 5, Positive serologic results Cystatin C > 1.26mg/L
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 mg (JW Pharmaceutical)Test product. A single oral dose of 1 tablet containing 9 mg of Epaminurad. | Drug | Group 1, Group 2 |
| Epaminurad 9 mg (Shanghai STA Pharmaceutical)Reference product. A single oral dose of 1 tablet containing 9 mg of Epaminurad. | Drug | Group 1, Group 2 |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: 3 days
To evaluate the AUC of Epaminurad
Peak plasma concentrations (Cmax)
Time frame: 3 days
To evaluate the Cmax of Epaminurad
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 Aug 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.
Seol Ju Moon principal investigator
Jeonbuk 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 (JW Pharmaceutical) and Epaminurad 9 mg (Shanghai STA Pharmaceutical) in people with Healthy, 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 2 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 Aug 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: 3 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 13 Aug 2026.