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

Launched by JW PHARMACEUTICAL · May 24, 2024

Keywords

ClinConnect Summary

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

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

Trial Officials