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

Launched by JW PHARMACEUTICAL · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is a Phase 1 study designed to investigate the safety and effects of two medications, Epaminurad and Naproxen, when taken together in healthy volunteers. The goal is to understand how these drugs interact with each other and how they are processed in the body. This study is not yet recruiting participants, but it aims to include individuals aged 19 to 50 years, who weigh between 50 to 90 kg and have a body mass index (BMI) between 18 and 30. The trial will focus on healthy Korean and Caucasian volunteers.

If you are considering participating, you should be aware that certain health conditions may exclude you from the study. For example, individuals with chronic liver disease, diabetes, or high blood pressure, among other medical issues, will not be eligible. During the trial, participants can expect to receive close monitoring to ensure their safety and well-being throughout the study. This trial is an early-stage investigation, which means it's crucial for understanding how these medications work together before they are tested in larger groups of people.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 19\~50
• • 2. 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
• • 3. Part 1: Korean/ Part 2: Caucasian
• 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) \< 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 Cystatin C \> 1.26mg/L (man), \> 1.19 mg/L (woman)