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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 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

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 treatment

The 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

Page last updated: August 23, 2015

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