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The purpose of this study is to determine if Digoxin is affected by PA21.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA21 and Digoxin with food | Experimental | The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Digoxin will be 0.5 mg/day |
|
| No PA21; Digoxin with food | Experimental | The maximum dosage of Digoxin will be 0.5 mg/day |
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| PA21 with food and Digoxin 2hrs later | Experimental | The maximum dose of PA21 will be 15 g/day. The maximum dose of Digoxin will be 0.5 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 and 96 hours post digoxin 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 and 96 hours post Digoxin 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 and 96 hours post Digoxin dose on days 0, 11, 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Winkle, MD | ACRI - Phase 1 (Advanced Clinical Research Institute) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACRI - Phase 1 | Anaheim | California | 92801 | United States |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Digoxin | Drug | The maximum dosage of Digoxin will be 0.5 mg/day |
|
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |