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The purpose of this study is to determine if Furosemide is affected by PA21.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA21 and Furosemide with food | Experimental |
| |
| No PA21; Furosemide with food | Experimental |
| |
| PA21 with food and Furosemide 2hrs later | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PA21 and Furosemide with food | Drug | The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Furosemide will be 40 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of PA21 on Furosemide | To assess the effect, if any, of PA21 on Furosemide exposure(AUC0-24; AUC0-infinity; Cmax; Tmax and t1/2). | PK assessment on Day 0, 11, and 22: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hrs post furosemide dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J 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 |
|---|---|
| D005665 | Furosemide |
| D005502 | Food |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| No PA21; Furosemide with food | Drug | The maximum dosage of Furosemide will be 40 mg/day |
|
| PA21 with food and Furosemide 2hrs later | Drug | The maximum dose of PA21 will be 15 g/day. The maximum dose of Furosemide will be 40 mg/day |
|
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |