Study to Evaluate the Interaction Between Aspirin and Nexium

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Esomeprazole; Drug: Aspirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01199328

D961FC00011

Details and patient eligibility

About

The purpose of this study is to assess the interaction between aspirin and Nexium in healthy volunteers.

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision informed consent prior to any study specific procedures.
• Healthy male and female subjects aged 18 to 75 years with suitable veins for cannulation or repeated vein puncture.
• Healthy female subjects must be of non-childbearing potential (post-menopausal, had a hysterectomy and/or bilateral oophorectomy) or be of childbearing potential and have a negative serum hCG pregnancy test during screening and be using of the following methods of birth control:
• Continuously practice abstinence during screening and throughout the duration of the study
• Clinically accepted contraception as described under item 7 of Section 5.1 and on hormonal contraceptives.
• Have a body mass index (BMI) between 19 and 30 kg/m2
• No clinically significant abnormal findings as judged by the Investigator on enrollment physical exam.

Exclusion criteria

• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
• Previous enrolment or randomisation in the present study.
• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study e.g. history of any bleeding disorder, excessive bruising or ongoing or history of liver disease
• History or presence of clinically significant gastrointestinal e.e. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

1

Active Comparator group

Description:

Aspirin 81 mg

Treatment:

Drug: Aspirin

2

Active Comparator group

Description:

Esomeprazole 20mg/aspirin 81mg

Treatment:

Drug: Esomeprazole

Drug: Aspirin