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A Study to Evaluate Platlet Aggregation of Clopidogrel, EC Aspirin 81 mg, EC Omeprazole 40 mg Compare to PA32540

NCT01557335 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-03-19

No results posted yet for this study

Summary

This study is designed to provide data on platelet aggregation of PA32540 plus clopidogrel dosed separately compared to EC aspirin 81 mg plus EC omeprazole 40 mg plus clopidogrel dosed concomitantly.

Conditions

  • Platelet Aggregation

Interventions

DRUG

Plavix® and PA32540

one Plavix® 300 mg loading dose in the PM of Day 1 one Plavix® 75 mg maintenance dose in the PM of Days 2-7 PA32540(delayed release aspirin 325 mg plus immediate release omeprazole 40 mg)

DRUG

EC aspirin (Bayer®) ,EC omeprazole (Prilosec®) , Clopidogrel (Plavix®)

One EC aspirin (Bayer®) 81 mg tablet plus one EC omeprazole (Prilosec®) 40 mg capsule plus one Clopidogrel (Plavix®) tablet of 300 mg (loading dose) all One EC aspirin (Bayer®) 81 mg tablet plus one EC omeprazole (Prilosec®) 40 mg capsule plus one Clopidogrel (Plavix®) tablet of 75 mg (maintenance dose) all taken concomitantly in the AM of Days 2-7

Sponsors & Collaborators

  • POZEN

    lead INDUSTRY

Principal Investigators

  • Lisa Zimmerman · POZEN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-02-28
Completion
2011-02-28

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 NCT01557335 on ClinicalTrials.gov