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A Phase 1 Study to evaluate the safety, PK/PD, drug-drug interaction(DDI) of Epaminurad and Naproxen in Healthy Volunteers
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Epaminurad 6 mg, Epaminurad 9 mg, Naproxen 500 mg |
|
| Part 2(Test group) | Experimental | Epaminurad 6 mg, Epaminurad 9 mg |
|
| Part 2(Control group) | Placebo Comparator | Epaminurad 6 mg placebo, Epaminurad 9 mg placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epaminurad, Naproxen | Drug | Period 1: Epaminurad 6mg -> Epaminurad 9mg -> Epaminurad 9mg +Naproxen Period 2: Naproxen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | To evaluate the AUC of Naproxen | 5 days |
| Area under the plasma concentration versus time curve (AUC) | To evaluate the AUC of Epaminurad | 7 days |
| Peak plasma concentrations (Cmax) | To evaluate the Cmax of Epaminurad | 7 days |
| Peak plasma concentrations (Cmax) | To evaluate the Cmax of Naproxen | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-sang Yu, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| C000706548 | URC102 |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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PART 1: A open-label, multiple-dose, single group/ PART 2: A placebo-controlled, randomized, double-blind, multiple-dose, parallel group
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PART 1: None (Open Label)/ PART 2: Double (Participant, Investigator)
| Epaminurad | Drug | Epaminurad |
|
|
| Epaminurad placebo | Drug | Epaminurad placebo |
|
|
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |