NCT06435442

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

A Phase 1 Study to Evaluate the Safety and PK/PD Drug-drug Interaction Between Epaminurad and Naproxen or to Assess the Safety and Multiple-Dose PK/PD Characteristics of Epaminurad in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Part 1: to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and Naproxen in Healthy Koreans/ Part 2: to evaluate the safety, PK/PD of Epaminurad in Healthy Caucasians

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Epaminurad, Naproxen	Period 1: Epaminurad 6mg -\> Epaminurad 9mg -\> Epaminurad 9mg +Naproxen Period 2: Naproxen
DRUG	Epaminurad	Epaminurad
DRUG	Epaminurad placebo	Epaminurad placebo

Timeline

• Start date: 2024-06-03
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-05-30
• Last updated: 2026-04-16

Locations

1 site across 1 country: South Korea