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A Healthy Female and Male Volunteers Aspirin Study

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: September 22, 2011
Last updated: May 9, 2012
Last verified: May 2012
This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between Esomeprazole and Aspirin after multiple dose administration.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 54
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01448031

United Kingdom
Research Site
London, UK, United Kingdom
Sponsors and Collaborators
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
  More Information

Responsible Party: AstraZeneca Identifier: NCT01448031     History of Changes
Other Study ID Numbers: D961FC00012
Study First Received: September 22, 2011
Last Updated: May 9, 2012

Keywords provided by AstraZeneca:
Acetyl Salicylic Acid
Healthy Volunteers

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors processed this record on April 24, 2017