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

Launched by JW PHARMACEUTICAL · Oct 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two medications, Epaminurad and C2406, to understand how they work in the body and how they interact with each other when taken together. The trial is specifically looking for healthy volunteers aged between 19 and 50 years who weigh between 50 to 90 kg. Participants should have a normal body mass index (BMI) and no history of certain health conditions, like chronic liver disease or diabetes, which could affect the study's results.

If you decide to participate, you'll be one of the first to help researchers learn about the safety and effects of these medications in healthy individuals. The trial is currently not recruiting, but when it begins, participants can expect to undergo various health checks to ensure they meet the eligibility criteria. It's important to know that people with specific health issues, such as high liver enzymes or abnormal kidney function, will not be eligible for this study. Your involvement could contribute to important medical research that may benefit others in the future.

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
• 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