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OpenTrials
Completed

NCT Number: NCT06665425

PK,PD and DDI of Epaminurad and C2406 in Healthy Volunteers

A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and C2406 in Healthy Volunteers

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Key information

Conditions

Healthy Volunteers

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital Clinical Trials Center

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 19~50
  • Weight: between 50.0 kg~90.0 kg, 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) < 90mL/min/1.73m^2
  • Serum uric acid < 3 mg/dL or > 7 mg/dL
  • AST (SGOT), ALT (SGPT) > upper limit of normal ranges X 1.5
  • Total bilirubin, γ-GTP > upper limit of normal ranges X 1.5
  • CK > upper limit of normal ranges X 2
  • Positive serologic results

Treatment and study plan

Epaminurad 9 mg

Drug

Period 1: Epaminurad / Period 2: C2406 -> Epaminurad + C2406

C2406

Drug

Period 1: Epaminurad / Period 2: C2406 -> Epaminurad + C2406

Primary outcomes

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

    Time frame: 7 days

    To evaluate the AUC of Epaminurad and C2406

  2. Peak plasma concentrations (Cmax)

    Time frame: 7 days

    To evaluate the Cmax of Epaminurad and C2406

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

An Open-label, Crossover, Phase 1 Clinical Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Drug-drug Interactions and Safety/Tolerability of Epaminurad and C2406 When Co-administered in Healthy Adults

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
Registry last updated
Apr 20, 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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