To Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers

August 12, 2026 updated by: JW Pharmaceutical

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Jeonju, South Korea
        • Jeonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Test product. A single oral dose of 1 tablet containing 9 mg of Epaminurad.
Drug: Epaminurad 9 mg (Shanghai STA Pharmaceutical)
Reference product. A single oral dose of 1 tablet containing 9 mg of Epaminurad.
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)
Test product. A single oral dose of 1 tablet containing 9 mg of Epaminurad.
Drug: Epaminurad 9 mg (Shanghai STA Pharmaceutical)
Reference product. A single oral dose of 1 tablet containing 9 mg of Epaminurad.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration versus time curve (AUC)
Time Frame: 3 days
To evaluate the AUC of Epaminurad
3 days
Peak plasma concentrations (Cmax)
Time Frame: 3 days
To evaluate the Cmax of Epaminurad
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Seol Ju Moon, Jeonbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2026

Primary Completion (Actual)

February 19, 2026

Study Completion (Actual)

February 24, 2026

Study Registration Dates

First Submitted

January 1, 2026

First Submitted That Met QC Criteria

January 25, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • JW25103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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