Healthy
Conditions
Brief 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
Interventions
DRUGEpaminurad 9 mg (JW Pharmaceutical)
Test product. A single oral dose of 1 tablet containing 9 mg of Epaminurad.
DRUGEpaminurad 9 mg (Shanghai STA Pharmaceutical)
Reference product. A single oral dose of 1 tablet containing 9 mg of Epaminurad.
Sponsors
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized, open-label, single dose, 2x2 crossover
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | 3 days | To evaluate the AUC of Epaminurad |
| Peak plasma concentrations (Cmax) | 3 days | To evaluate the Cmax of Epaminurad |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORSeol Ju Moon
Jeonbuk National University Hospital
Outcome results
None listed