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The purpose of this study is to determine if Warfarin is affected by PA21.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA21 and Warfarin with food | Experimental | The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Warfarin will be 10 mg/day |
|
| No PA21; Warfarin with food | Experimental | The maximum dosage of Warfarin will be 10 mg/day |
|
| PA21 with food and Warfarin 2hrs later | Experimental | The maximum dose of PA21 will be 15 g/day. The maximum dose of Warfarin will be 10 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PA21 | Drug | The maximum dose of PA21 will be 15.0 g/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve from time zero to 24 hours (AUC0-24) | Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post Warfarin dose on Days 0, 11, 22 |
| Area Under the Curve from time zero to infinite (AUC0-infinity) | Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post Warfarin dose on Days 0, 11, 22 |
| Maximum observed plasma concentration (Cmax) | pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post Warfarin dose on days 0, 11, 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra K Willsie, MD | PRA International - Clinical Pharmacology Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International - Clinical Pharmacology Center | Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Warfarin | Drug | The maximum dosage of Warfarin will be 10 mg/day |
|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |