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To demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.) |
|
| 2 | Active Comparator | Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine Sulfate Tablets, 200 mg (Geneva Pharmaceutical, Inc.) | Drug |
| ||
| Hydroxychloroquine Sulfate Tablets, 200 mg, Plaquenil (Sanofi Winthrop) |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on AUC and Cmax | 171 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Gantt, M.D. | PharmaKinetics Laboratories Inc. | Principal Investigator |
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| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| C076644 | Trifyba |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Drug |
|
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |