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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: omeprazole; Drug: lansoprazole; Drug: clopidogrel; Drug: esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01147588

D9612C00034

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males within the age of 18-45 years and females within the age of 18-55 years with suitable veins for cannulation or repeated vein puncture. Females must be of non-childbearing potential.
• Weight of 50-95kg, inclusive, and a BMI between 19-30 kg/m2, inclusive.
• No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.

Exclusion criteria

• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in study.
• History or presence of gastrointestinal e.g. GI ulcer, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
• Any clinically significant illness within 4 weeks of the first administration of investigational product. Any medical/surgical procedure or trauma within 3 months of the treatment period; scheduled surgery, including dental surgery within 2 weeks.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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149 participants in 4 patient groups

1

Experimental group

Description:

lansoprazole 60 mg + clopidogrel 300 mg/ 75 mg

Treatment:

Drug: lansoprazole

Drug: clopidogrel

2

Experimental group

Description:

omeprazole 80 mg + clopidogrel 300/75 mg

Treatment:

Drug: omeprazole

Drug: clopidogrel

3

Experimental group

Description:

esomeprazole 40 mg + clopidogrel 300/75 mg

Treatment:

Drug: clopidogrel

Drug: esomeprazole

4

Experimental group

Description:

clopidogrel 300/75 mg alone

Treatment:

Drug: clopidogrel