A Healthy Female and Male Volunteers Aspirin Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01448031
First received: September 22, 2011
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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).

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448031

Locations
United Kingdom
Research Site
London, UK, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01448031     History of Changes
Other Study ID Numbers: D961FC00012
Study First Received: September 22, 2011
Last Updated: May 9, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Acetyl Salicylic Acid
Bioavailability
Healthy Volunteers

Additional relevant MeSH terms:
Aspirin
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 15, 2014