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This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.
This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the 2 different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence B | Experimental | Day 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1) |
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| Sequence A | Experimental | Day 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lesinurad 400 mg (manufactured at Site 1) | Drug |
| ||
| Lesinurad 400 mg (manufactured at Site 2) |
| 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 from zero to 24 hours post dose (AUC last) and from zero to infinity (AUC ∞); and apparent terminal half-life (t1/2). Point estimates and 90% confidence intervals for the ratio of geometric means for Cmax, AUC last and AUC∞ between test and reference formulations. | 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 | Ardea Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| C000593471 | lesinurad |
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| Drug |
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