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Study Evaluating Effect of Esomeprazole, Omeprazole or Lansoprazole on the Pharmacodynamics (PD) and Pharmacokinetics (PK) of Clopidogrel

NCT01147588 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2011-06-28

No results posted yet for this study

Summary

The aim of this study is to determine if there is a pharmacological interaction between clopidogrel and different types of proton pump inhibitors (PPIs), and if the extent of this possible interaction would change over time.

Conditions

  • Healthy

Interventions

DRUG

lansoprazole

60 mg (2x30-mg capsule), once daily

DRUG

omeprazole

80 mg (2x40-mg capsule), once daily

DRUG

esomeprazole

40 mg (1x40-mg capsule), once daily

DRUG

clopidogrel

300 mg loading dose on Day 1 then 75 mg daily for 28 days

Sponsors & Collaborators

Principal Investigators

  • Kelli Craven, MD · Quintiles, Inc.

  • Ken Price · AstraZeneca

  • Mirjana Kujacic · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01147588 on ClinicalTrials.gov