A Healthy Female and Male Volunteers Aspirin Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Capsule ASA 81mg/esomeprazole 20mg; Drug: Acetylsalicylzuur Apotex Cardio

• Registration Number: NCT01448031
• Lead Sponsor: AstraZeneca

Brief Summary

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

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 Timeline

• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Study Start: 2011-11
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-09
• Last Update Posted: 2012-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Capsule ASA 81mg/esomeprazole 20mg	Capsule ASA 81mg/esomeprazole 20mg
2	Acetylsalicylzuur Apotex Cardio	ASA (Acetylsalicylzuur Apotex cardio 80 mg) Tablet 80 mg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, UK, United Kingdom