A Healthy Female and Male Volunteers Aspirin Study
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)
1 other identifier
interventional
54
1 country
1
Brief Summary
This is a study to compare the bioavailability of Acetyl Salicylic Acid (ASA) between Esomeprazole and Aspirin after multiple dose administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Nov 2011
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMay 10, 2012
May 1, 2012
5 months
September 22, 2011
May 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
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.
Day 5
Secondary Outcomes (1)
Description of the safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, safety labs
Pre-dose up to 7 day after last dose
Study Arms (2)
1
EXPERIMENTALCapsule ASA 81mg/esomeprazole 20mg
2
ACTIVE COMPARATORASA (Acetylsalicylzuur Apotex cardio 80 mg) Tablet 80 mg
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
London, UK, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2011
First Posted
October 7, 2011
Study Start
November 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
May 10, 2012
Record last verified: 2012-05