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

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

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

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)