Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated Aspirin in Diabetic Patients
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 21 - 79 |
| Updated: | 4/21/2016 |
| Start Date: | January 2014 |
| End Date: | April 2014 |
Reliable Inhibition of Thrombocyte Activity: Comparison of PL2200 Aspirin Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study)
This study will determine if aspirin from PL2200, an investigational product, gets into the
blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to
prevent blood clots as effectively as enteric coated aspirin, when administered to patients
with diabetes
blood stream as quickly as enteric coated aspirin, and to test whether PL2200 is able to
prevent blood clots as effectively as enteric coated aspirin, when administered to patients
with diabetes
Inclusion Criteria:
- Non-Insulin-Dependent Diabetes Mellitus
- Adults 21 to 79 years, inclusive
- Body mass index between 30 and 40 kg/m2, inclusive
Exclusion Criteria:
- Currently prescribed aspirin or anti-coagulants
- Contraindications to aspirin
- Significant disease history or active disease other than Non-Insulin-Dependent
Diabetes Mellitus
- Patient requires insulin
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