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The purpose of this study is to determine if Omeprazole is affected by PA21.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA21 and Omeprazole with food | Experimental |
| |
| No PA21; Omeprazole with food | Experimental |
| |
| PA21 with food, Omeprazole 2 hrs later | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PA21 and Omeprazole with food | Drug | The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Omeprazole will be 40 mg/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, 3.5, 4, 5, 6, 8, 12, 24 hours post omeprazole 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, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22 |
| Maximum observed plasma concentration (Cmax) | pre-dose, 0.25, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 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 |
|---|---|
| D009853 | Omeprazole |
| D005502 | Food |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| No PA21; Omeprazole with food | Drug | The maximum dosage of Omeprazole will be 40 mg/day |
|
| PA21 with food, Omeprazole 2hrs later | Drug | The maximum dose of PA21 will be 15 g/day. The maximum dose of Omeprazole will be 40 mg/day |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |