PK,PD and DDI of Epaminurad and Naproxen in Healthy Volunteers
Phase 1
Not yet recruiting
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT06435442
- Lead Sponsor
- JW Pharmaceutical
- Brief Summary
A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and Naproxen in Healthy Volunteers
- Detailed Description
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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Age: 19~50
- 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
- Part 1: Korean/ Part 2: Caucasian
Exclusion Criteria
- Medical history- chronic liver disease, acute gout attack, uric acid stone, diabetes, hypertension, hyperlipidemia or lipid abnormality
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 Epaminurad, Naproxen Epaminurad 9 mg, Naproxen 500 mg Part 2(Test group) Epaminurad Epaminurad 9 mg Part 2(Control group) Epaminurad placebo Epaminurad 9 mg placebo
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) 7 days To evaluate the AUC of Epaminurad and Naproxen
Peak plasma concentrations (Cmax) 7 days To evaluate the Cmax of Epaminurad and Naproxen
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of