Reliable Inhibition of Thrombocyte Activity: Comparison of PL2200 Aspirin Capsules, 325 mg and Enteric-Coated Aspirin (RITE Study)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 57
- Locations
- 3
- Primary Endpoint
- Time to 99% Inhibition of Serum Thromboxane
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PL2200 Aspirin Capsules
PL2200 Aspirin Capsules
Intervention: PL2200 Aspirin Capsules (Drug)
Enteric-coated aspirin caplets
Enteric-coated aspirin caplets
Intervention: Enteric-coated aspirin caplets (Drug)
Outcomes
Primary Outcomes
Time to 99% Inhibition of Serum Thromboxane
Time Frame: 11 days
Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.
Secondary Outcomes
No secondary outcomes reported