NCT06665425CompletedPhase 1
An Open-label, Crossover, Phase 1 Clinical Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Drug-drug Interactions and Safety/Tolerability of Epaminurad and C2406 When Co-administered in Healthy Adults
JW Pharmaceutical1 site in 1 country18 target enrollmentStarted: March 24, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration versus time curve (AUC)
Study Overview
Brief Summary
A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and C2406 in Healthy Volunteers
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
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
Arms & Interventions
Arm 1
Experimental
Epaminurad 9mg, C2406 0.6mg
Intervention: Epaminurad 9 mg (Drug)
Arm 1
Experimental
Epaminurad 9mg, C2406 0.6mg
Intervention: C2406 (Drug)
Outcomes
Primary Outcomes
Area under the plasma concentration versus time curve (AUC)
Time Frame: 7 days
To evaluate the AUC of Epaminurad and C2406
Peak plasma concentrations (Cmax)
Time Frame: 7 days
To evaluate the Cmax of Epaminurad and C2406
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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