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Pharmacodynamic Evaluation of PL2200 Versus Enteric-Coated and Immediate Release Aspirin in Diabetic Patients

NCT01515657 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-03-14

Study results available
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Summary

This study will determine if aspirin from PL2200, an investigational product, gets into the blood stream as quickly as plain aspirin and enteric coated aspirin, and to test whether PL2200 is able to prevent blood clots as effectively as these other products, when administered to patients with diabetes.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

PL2200 Aspirin Capsules

325 mg aspirin; once per day for 3 days

DRUG

Immediate-Release Aspirin Tablets

325 mg aspirin; once per day for 3 days

DRUG

Enteric-coated aspirin caplets

325 mg aspirin; once per day for 3 days

Sponsors & Collaborators

  • PLx Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01515657 on ClinicalTrials.gov