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The purpose of this study is to determine if Losartan potassium is affected by PA21.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA21 and Losartan with food | Experimental |
| |
| No PA21; Losartan with food | Experimental |
| |
| PA21 with food and Losartan 2 hrs later | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PA21 and Losartan with Food | Drug | The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of PA21 on Losartan potassium | To assess the effect, if any, of PA21 on Losartan potassium exposure | PK assessment on Day 0, 11, 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of PA21 on the active metabolite of Losartan potassium | To assess the effect, if any, of PA21 on the active metabolite of Losartan potassium | PK assessment on Day 0, 11, 22 |
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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 |
|---|---|
| D019808 | Losartan |
| D005502 | Food |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| No PA21; Losartan with food | Drug | The maximum dose of Losartan will be 100 mg/day. |
|
| PA21 with food and Losartan 2 hours later | Drug | The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day. |
|
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |