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A Healthy Female and Male Volunteers Aspirin Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01448031
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : May 10, 2012
Information provided by (Responsible Party):

Brief Summary:
This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between Esomeprazole and Aspirin after multiple dose administration.

Condition or disease Intervention/treatment Phase
Healthy Drug: Capsule ASA 81mg/esomeprazole 20mg Drug: Acetylsalicylzuur Apotex Cardio Phase 1

Detailed Description:
A Phase I, open-label, randomized, two way crossover pharmacokinetic study comparing the bioavailability of acetylsalicylic acid (ASA) after 5 days repeated once daily administration of a fixed dose combination capsule of ASA 81 mg/esomeprazole 20 mg and ASA 80 mg (European aspirin reference product).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase I, Open-label, Randomized, Two Way Crossover Pharmacokinetic Study Comparing the Bioavailability of Acetylsalicylic Acid (ASA) After 5 Days Repeated Once Daily Administration of a Fixed Dose Combination Capsule of ASA 81 mg/Esomeprazole 20 mg and ASA 80 mg (European Aspirin Reference Product)
Study Start Date : November 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Capsule ASA 81mg/esomeprazole 20mg
Drug: Capsule ASA 81mg/esomeprazole 20mg
Multiple doses administered on Day 1 to 5

Active Comparator: 2
ASA (Acetylsalicylzuur Apotex cardio 80 mg) Tablet 80 mg
Drug: Acetylsalicylzuur Apotex Cardio
Multiple doses administered on Day 1 to 5

Primary Outcome Measures :
  1. pharmacokinetic profile of acetylsalicylic acid (ASA) and salicylic acid (SA) in terms of area under curve (AUC), maximum concentration at steady state (Css,max), time to reach maximum concentration (tmax) and terminal half- time (t1/2). [ Time Frame: Day 5 ]
    PK samples collected pre-dose and at 5mins, 10 mins, 20 mins, 30 mins, 40mins, 50 mins, 1hr 15 mins, 1.5hrs, 2 hrs, 2hr 30 mins, 3hrs, 3hr 30 mins, 4 hrs, 5 hrs, 6hrs, 8hrs,10 hrs, 12hrs post-dose.

Secondary Outcome Measures :
  1. Description of the safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, safety labs [ Time Frame: Pre-dose up to 7 day after last dose ]
    No formal statistical tests will be performed. Abnormalities will be listed without statistical analysis

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male and female subjects aged 20 to 50 years inclusive.
  • Have a body body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and weigh 50.0 to 100.0 kg inclusive.
  • Females must be of non-childbearing potential or be of childbearing potential but have a negative serum hCG pregnancy test during screening and on admission.

Exclusion Criteria:

  • 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.
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator.
  • History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01448031

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United Kingdom
Research Site
London, UK, United Kingdom
Sponsors and Collaborators
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Principal Investigator: Ronnie Beboso BioKinetic Europe Ltd,14 Great Victoria Street,Belfast, N.Ireland,United Kingdom BT2 7BA
Study Director: Tore Lind AstraZeneca, Pepparedsleden 1 431 83 Molndal Sweden
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Responsible Party: AstraZeneca Identifier: NCT01448031    
Other Study ID Numbers: D961FC00012
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: May 10, 2012
Last Verified: May 2012
Keywords provided by AstraZeneca:
Acetyl Salicylic Acid
Healthy Volunteers
Additional relevant MeSH terms:
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Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action