Study identifier:D9612C00034
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
An open-label, randomized, 4-treatment, 3-period, crossover interaction study, evaluating the effect of esomeprazole 40 mg, omeprazole 80 mg or lansoprazole 60 mg on the pharmacodynamics and the pharmacokinetics of clopidogrel in healthy volunteers
Healthy
Phase 1
Yes
lansoprazole, omeprazole, esomeprazole, clopidogrel
All
149
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
Location
Location
Overland Park, KS, United States
Arms | Assigned Interventions |
---|---|
Experimental: 1 lansoprazole 60 mg + clopidogrel 300 mg/ 75 mg | Drug: lansoprazole 60 mg (2x30-mg capsule), once daily Drug: clopidogrel 300 mg loading dose on Day 1 then 75 mg daily for 28 days |
Experimental: 2 omeprazole 80 mg + clopidogrel 300/75 mg | Drug: omeprazole 80 mg (2x40-mg capsule), once daily Drug: clopidogrel 300 mg loading dose on Day 1 then 75 mg daily for 28 days |
Experimental: 3 esomeprazole 40 mg + clopidogrel 300/75 mg | 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 |
Experimental: 4 clopidogrel 300/75 mg alone | Drug: clopidogrel 300 mg loading dose on Day 1 then 75 mg daily for 28 days |
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