A Healthy Female and Male Volunteers Aspirin Study

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01448031

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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).

Study Design

Study Type:

Interventional

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 :

Nov 1, 2011

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

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

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

Outcome Measures

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). [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 [Pre-dose up to 7 day after last dose]
No formal statistical tests will be performed. Abnormalities will be listed without statistical analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01448031

Other Study ID Numbers:

D961FC00012

First Posted:

Oct 7, 2011

Last Update Posted:

May 10, 2012

Last Verified:

May 1, 2012

Keywords provided by AstraZeneca

Acetyl Salicylic Acid

Bioavailability

Healthy Volunteers

Additional relevant MeSH terms:

Esomeprazole

Study Results

No Results Posted as of May 10, 2012