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To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fasted state based on the pharmacokinetic (PK) evaluation of lesinurad and allopurinol in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence ABBA | Experimental | Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2). |
|
| Sequence BABA | Experimental | Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2). |
|
| Sequence ABAB | Experimental | Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2). |
|
| Sequence BAAB | Experimental | Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lesinurad/allopurinol 200/300 FDC tablets | Drug | Test Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) endpoints in terms of maximum observed concentration (Cmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets | Cmax is the maximum observed concentration of a drug after administration | Days 1, 8, 15 and 22 |
| PK endpoints in terms of area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint (AUC last) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets | AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint | Days 1, 8, 15 and 22 |
| PK endpoints in terms of area under the plasma concentration time curve from and from zero to infinity (AUC 0-∞) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets | AUC 0-∞ is a meausre of total concentration from time zero to infinity | Days 1, 8, 15 and 22 |
| PK endpoints in terms of time of occurrence of maximum observed concentration (tmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets | Tmax is the time of occurrence of cmax | Days 1, 8, 15 and 22 |
| PK endpoints in terms of apparent terminal half-life (t1/2) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets | t1/2 is a measure of apparent terminal half-life | Days 1, 8, 15 and 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events in terms of changes in laboratory parameters | 26 days | |
| Incidence of Adverse Events in terms of electrocardiogram parameters | 26 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| N. Bhakta | Ardea Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAEP - Centro Avançado de Estudos e Pesquisas Ltda. | Campinas | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| C000593471 | lesinurad |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| lesinurad 200 mg | Drug | Comparator 1 |
|
| allopurinol 300 mg | Drug | Comparator 2 |
|
| Incidence of Adverse Events in terms of vital signs |
| 26 days |
| Incidence of Adverse Events in terms of physical examination findings | 26 days |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |