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Completed
NCT07374406
To Evaluate the Safety and Pharmacokinetic Characteristics in Healthy Volunteers
Conditions: Healthy
Sex: All
Ages: 19 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 34
Sponsor: JW Pharmaceutical
Location: Jeonbuk National University Hospital Jeonju
Summary
A randomized, open-label, single dose, 2x2 crossover study to evaluate the safety and pharmacokinetic characteristics after administration of Epaminurad in healthy adult volunteers under fasting conditions
Eligibility Criteria
Inclusion Criteria:
1. Age: 19\~55
2. Weight: at least 50 kg for males and 45 kg for females. 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) \< 60mL/min/1.73m\^2, AST (SGOT), ALT (SGPT) \> upper limit of normal ranges X 2, CK \> upper limit of normal ranges X 5, Positive serologic results Cystatin C \> 1.26mg/L
Source: ClinicalTrials.gov (NCT07374406). StuddyBuddy aggregates publicly available trial information.
