An Interaction Study to Evaluate the Effect of Esomeprazole/Acetylsalicylic Acid on the Metabolism and Effect of Clopidogrel
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteers
Intervention: Clopidogrel (Drug); Esomeprazole/ASA (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Peter Nagy, MD, Study Director, Affiliation: AstraZeneca
Summary
The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic
Acid (ASA) 81 mg affect the metabolism of clopidogrel.
Clinical Details
Official title: An Open-label, Randomized, Single-center, 2-way Cross-over Interaction Study, Evaluating the Effect of Esomeprazole 20 mg/Acetylsalicylic Acid 81 mg on the Pharmacodynamics and the Pharmacokinetics of Clopidogrel on Days 1 and 9 in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baselineThe effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacodynamics of clopidogrel by assessing maximal inhibition of platelet aggregation after 9 days of clopidogrel treatment relative to baseline
Secondary outcome: The effect of esomeprazole 20 mg/ acetylsalicylic acid 81 mg on the pharmacokinetics of the active metabolite of clopidogrel by assessing Area Under Curve (AUC) and Cmax.after 9 days of clopidogrel treatmentThe safety and tolerability of clopidogrel alone and in combination with esomeprazole/ acetylsalicylic acid
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male (aged between 18 and 45 years inclusive) or female (aged between 18 and 55 years
inclusive) healthy volunteers
- Female healthy volunteers must be of non-childbearing potential or be of
childbearing potential, be non-lactating and have a negative pregnancy test during
the pre-entry visit and be using 1 clinically accepted method of contraception
- Have a body mass index between 19 and 30 kg/m2 inclusive
- No clinically significant abnormal findings at the physical examination as judged by
the investigator
Exclusion Criteria:
- Any clinically significant abnormalities in laboratory screening results as judged by
investigator
- Platelet count <150 x 10^9/L on Day -1 or any other conditions that would increase
the risk of bleeding
- Previous bone marrow transplant
- Any clinically important abnormalities in rhythm, conduction or morphology of resting
ECG
Locations and Contacts
Research Site, Uppsala, Sweden
Additional Information
Starting date: November 2010
Last updated: October 6, 2011
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