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This trial is a food-effect study to assess fasted versus fed pharmacokinetics of PL2200.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PL2200 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PL2200 fasted | Drug | Fasted state |
| |
| PL2200 fed |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of food by ratio of least-squares means (LSM) of the pharmacokinetic (PK) parameter of AUC0-t of the primary metabolite, salicylic acid, in the fed state versus the fasted state. | 24 hours | |
| Effect of food by ratio of least-squares means (LSM) of the PK parameter of AUC0-inf of the primary metabolite, salicylic acid, in the fed state versus the fasted state. | 24 hours | |
| Effect of food by ratio of least-squares means (LSM) of the PK parameter of Cmax of the primary metabolite, salicylic acid, in the fed state versus the fasted state. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Upendra K Marathi, PhD | PLx Pharma Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Institute for Clinical Research | Houston | Texas | 77074 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32080811 | Derived | Angiolillo DJ, Bhatt DL, Lanza F, Deliargyris EN, Prats J, Fan W, Marathi U. Bioavailability of aspirin in fasted and fed states of a novel pharmaceutical lipid aspirin complex formulation. J Thromb Thrombolysis. 2020 Apr;49(3):337-343. doi: 10.1007/s11239-020-02051-5. |
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| Drug |
Fed state |
|