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This study will assess the relative bioavailability of lesinurad tablets, manufactured at two different sites.
A change in manufacturing site of lesinurad tablets has been implemented. This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the two different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot A) | Experimental | Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A) |
|
| Lesinurad 400 mg Fed (Site 1 and Site 2, Lot A) | Experimental | Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot A) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot A) |
|
| Lesinurad 400 mg Fasted (Site 1 and Site 2, Lot B) | Experimental | Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B) |
|
| Lesinurad 400 mg Fed (Site 1 and Site 2, Lot B) | Experimental | Day 1: Lesinurad 400 mg (Site 1 or Site 2, Lot B) Day 5: Lesinurad 400 mg (Site 1 or Site 2, Lot B) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lesinurad 400 mg (Site 1) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK profile of lesinurad from plasma | PK endpoints in terms of maximum observed concentration (Cmax); time of occurrence of maximum observed concentration (Tmax); area under the plasma concentration time curve (AUC); and apparent terminal half-life (t1/2). | Day 1 and Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Changes in Laboratory, Electrocardiogram and Vital Signs Parameters | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Hall, MD | Ardea Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glendale | California | 91206 | United States |
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| ID | Term |
|---|---|
| C000593471 | lesinurad |
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| Lesinurad 400 mg (Site 2, Lot A) | Drug |
|
| Lesinurad 400 mg (Site 2, Lot B) | Drug |
|