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The purpose of this study is to compare the safety, pharmacokinetics, and pharmacodynamic effects of aspirin administered intravenously with aspirin administered orally.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rho-11 administered in Period 1, oral aspirin administered in Period 2 | Experimental |
| |
| Oral aspirin administered in Period 1, Rho-11 administered in Period 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 325 mg Oral Aspirin | Drug | Drug: aspirin 325mg • Subjects will be administered 325 mg aspirin orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum thromboxane B2 from baseline | Change in serum thromboxane B2 from baseline to 180 minutes post treatment | 1 hour before dosing and 2, 5, 10, 20, 30, 45, 60, and 180 minutes post dosing] |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary 11-dehydro-TXB2 levels | Measured levels of 11-dehydro-TXB2 in urine following treatment | Every 12 hours from 24 hours prior to dosing to 72 hours after dosing. |
| Urinary 2,3-dinor-6-keto-PGF1alpha |
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Inclusion Criteria:
Each subject must meet all of the following criteria to be enrolled in this study:
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Purvis, MD | jpurvis@rhoshanpharma.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quinta-Analytica s.r.o. | Prague | Czechia |
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| 325 mg aspirin by rapid IV push | Drug | Drug: Rho-11 Subjects will be administered 325 mg aspirin by rapid IV push |
|
|
Measured levels of 2,3-dinor-6-keto-PGF1alpha in urine following treatment
| Every 12 hours from 24 hours prior to dosing to 72 hours after dosing. |
| Acetylsalicylic Acid Plasma Pharmacokinetics | Measured change in levels of acetylsalicylic acid in plasma following treatment | 1 hour prior to dosing, and 1,3,5,10,15,20,30, and 45 minutes and 1,1.5,2,3,6,8, and 24 hours postdosing. |
| Salicylic Acid Plasma Pharmacokinetics | Measured change in levels of salicylic acid in plasma following treatment | 1 hour prior to dosing, and 1,3,5,10,15,20,30, and 45 minutes and 1,1.5,2,3,6,8, and 24 hours postdosing. |
| ID | Term |
|---|---|
| D001241 | Aspirin |
| C091344 | DNA modification methylase phi3TII, Bacteriophage phi-3T |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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