Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Subjects receive a single dose of Treatment A (JW Pharmaceutical) in Period 1, followed by a washout period, and then a single dose of Treatment B (Shanghai STA Pharmaceutical) in Period 2. |
|
| Group 2 | Experimental | Subjects receive a single dose of Treatment B (Shanghai STA Pharmaceutical) in Period 1, followed by a washout period, and then a single dose of Treatment A (JW Pharmaceutical) in Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epaminurad 9 mg (JW Pharmaceutical) | Drug | Test product. A single oral dose of 1 tablet containing 9 mg of Epaminurad. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | To evaluate the AUC of Epaminurad | 3 days |
| Peak plasma concentrations (Cmax) | To evaluate the Cmax of Epaminurad | 3 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Seol Ju Moon | Jeonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeonbuk National University Hospital | Jeonju | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
randomized, open-label, single dose, 2x2 crossover
Not provided
Not provided
Not provided
Not provided
| Epaminurad 9 mg (Shanghai STA Pharmaceutical) | Drug | Reference product. A single oral dose of 1 tablet containing 9 mg of Epaminurad. |
|