Healthy Volunteers
Conditions
Keywords
Nexium, aspirin, peptic ulcers, pharmacodynamic (PD), Esomoeprazole
Brief summary
The purpose of this study is to assess the interaction between aspirin and Nexium in healthy volunteers.
Interventions
DRUGAspirin
81mg Tablet oral, once daily
DRUGEsomeprazole
20 mg Tablet oral, once daily
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Ongoing throughout the study from consent through withdrawal |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the effect of esomeprazole on low-dose aspirin pharmacodynamics by assessing the relative change in serum thromboxane B2 inhibition from baseline | Ongoing throughout the study from consent through withdrawal |
| Evaluate safety and tolerability of esomeprazole taken concurrently with low- dose aspirin | Ongoing throughout the study from consent through withdrawal |
Countries
United States
Outcome results
None listed