PK,PD and DDI of Epaminurad and Naproxen in Healthy Volunteers
Phase 1
- 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
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 48
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 Cystatin C > 1.26mg/L (man), > 1.19 mg/L (woman)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 Epaminurad, Naproxen Epaminurad 6 mg, Epaminurad 9 mg, Naproxen 500 mg Part 2(Test group) Epaminurad Epaminurad 6 mg, Epaminurad 9 mg Part 2(Control group) Epaminurad placebo Epaminurad 6 mg placebo, Epaminurad 9 mg placebo
- Primary Outcome Measures
Name Time Method Peak plasma concentrations (Cmax) 5 days To evaluate the Cmax of Naproxen
Area under the plasma concentration versus time curve (AUC) 7 days To evaluate the AUC of Epaminurad
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Epaminurad's pharmacodynamic effects when co-administered with Naproxen in healthy volunteers?
How does Epaminurad's drug-drug interaction profile with Naproxen compare to other NSAIDs in Phase 1 trials?
Which biomarkers are associated with Epaminurad's pharmacokinetic variability in Korean versus Caucasian healthy populations?
What adverse event management strategies are recommended for Epaminurad-Naproxen combinations based on NCT06435442 findings?
What are the therapeutic implications of Epaminurad's DDI results for future combination therapies in inflammatory diseases?
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital🇰🇷Seoul, Korea, Republic of