To Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers

NCT07374406 | Completed Phase 1

• 1 other identifier: JW25103
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration versus time curve (AUC)

  To evaluate the AUC of Epaminurad

  3 days

• Peak plasma concentrations (Cmax)

  To evaluate the Cmax of Epaminurad

  3 days

Study Arms (2)

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.

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.

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

Interventions

Epaminurad 9 mg (Shanghai STA Pharmaceutical) DRUG

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

Group 1; Group 2

Epaminurad 9 mg (JW Pharmaceutical) DRUG

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

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (1)

Jeonbuk National University Hospital

Jeonju, South Korea

Location

Study Officials

• Seol Ju Moon

  Jeonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, open-label, single dose, 2x2 crossover

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 28, 2026
• Study Start: February 2, 2026
• Primary Completion: February 19, 2026
• Study Completion: February 24, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)