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| Name | Class |
|---|---|
| POZEN | INDUSTRY |
The primary hypothesis of this study is that concomitant multiple-dose administration of PN 400 does not interfere with the platelet inhibitory effects of enteric-coated low-dose aspirin (81 mg), as measured by serum thromboxane B2 inhibition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | PN400 + ASA |
|
| 2 | Placebo Comparator | Placebo + ASA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PN400 | Drug | naproxen 500 mg/esomeprazole 20 mg oral tablet |
| |
| ASA |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic: Mean percent inhibition of serum thromboxane B2 | measured on the morning of Day 6 (Period 1), and 24 hours after the Day 10 morning dose of aspirin (ie, Day 11) in Period 2 | |
| Safety: Parameters include: physical examination, vital signs, clinical laboratory tests, adverse events | during approx 6 week study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Schutz, MD | Quintiles Phase 1 Services | Principal Investigator |
| Catherine Datto, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22078153 | Derived | Angiolillo DJ, Hwang C, Datto C, Desai B, Sostek M. Impact of a fixed-dose combination of naproxen and esomeprazole magnesium on serum thromboxane B2 inhibition by low-dose aspirin over 5 days in healthy adults: a phase I, randomized, double-blind, placebo-controlled, noninferiority trial. Clin Ther. 2011 Dec;33(12):1883-93. doi: 10.1016/j.clinthera.2011.10.009. Epub 2011 Nov 10. |
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| ID | Term |
|---|---|
| C010395 | acetylsalicylic acid lysinate |
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| Drug |
Asprin 81 mg enteric coated tablet |
|
|
| Placebo | Drug |
|