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CompletedNCT07374406Updated Aug 13, 2026

To Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers

A Phase 1 interventional study of Epaminurad 9 mg (JW Pharmaceutical) and Epaminurad 9 mg (Shanghai STA Pharmaceutical) in Healthy, sponsored by JW Pharmaceutical. Completed at 1 site in South Korea. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by JW Pharmaceutical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

JW Pharmaceutical is the lead sponsor of 75 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age: 19\~55
  2. 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

Exclusion criteria

Exclusion Criteria:

  1. Medical history- chronic liver disease, acute gout attack, uric acid stone, diabetes, hypertension, hyperlipidemia or lipid abnormality
  2. 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Group 1

    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.

    Drug: Epaminurad 9 mg (JW Pharmaceutical) · Drug: Epaminurad 9 mg (Shanghai STA Pharmaceutical)

  • Experimental
    Group 2

    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.

    Drug: Epaminurad 9 mg (JW Pharmaceutical) · Drug: Epaminurad 9 mg (Shanghai STA Pharmaceutical)

Interventions

  • DrugEpaminurad 9 mg (JW Pharmaceutical)

    Test product. A single oral dose of 1 tablet containing 9 mg of Epaminurad.

  • DrugEpaminurad 9 mg (Shanghai STA Pharmaceutical)

    Reference product. A single oral dose of 1 tablet containing 9 mg of Epaminurad.

06

What researchers measure

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC)

    To evaluate the AUC of Epaminurad

    Time frame: 3 days

  2. Peak plasma concentrations (Cmax)

    To evaluate the Cmax of Epaminurad

    Time frame: 3 days

07

Study locations

1 site
  • Jeonbuk National University Hospital
    Jeonju, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07374406
Lead sponsor
JW Pharmaceutical
Responsible party
Sponsor
First posted
Jan 28, 2026
Start date
Feb 2, 2026
Primary completion
Feb 19, 2026
Completion
Feb 24, 2026
Last update
Aug 13, 2026

Study contacts

Seol Ju Moon
principal investigator · Jeonbuk National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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