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OpenTrials
Completed

NCT Number: NCT07374406

To Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers

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

Completed

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jeonbuk National University Hospital

Jeonju, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 3 days

    To evaluate the AUC of Epaminurad

  2. Peak plasma concentrations (Cmax)

    Time frame: 3 days

    To evaluate the Cmax of Epaminurad

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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