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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No locations available
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 |