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OpenTrials
Completed

NCT Number: NCT01199328

Study to Evaluate the Interaction Between Aspirin and Nexium

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Springfield, Missouri, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin

Drug

81mg Tablet oral, once daily

Esomeprazole

Drug

20 mg Tablet oral, once daily

Other names: Nexium

Primary outcomes

  1. Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in the VerifyNow Aspirin test after 5 days of treatment, relative to baseline (Day 1) in healthy human volunteers

    Time frame: Ongoing throughout the study from consent through withdrawal

Secondary outcomes

  1. Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in serum thromboxane B2 inhibition from baseline

    Time frame: Ongoing throughout the study from consent through withdrawal

  2. Evaluate safety and tolerability of esomeprazole taken concurrently with low- dose aspirin

    Time frame: Ongoing throughout the study from consent through withdrawal

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Open, Two-way Crossover, Drug-drug Interaction Study Evaluating the Effect of Esomeprazole on the Pharmacodynamics of Acetylsalicylic Acid After 5 Days of Treatment

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 10, 2010
Registry last updated
Nov 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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