A Healthy Female and Male Volunteers Aspirin Study

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

Detailed Description
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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).

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Capsule ASA 81mg/esomeprazole 20mg
* Drug: Acetylsalicylzuur Apotex Cardio


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Capsule ASA 81mg/esomeprazole 20mg | Drug: Capsule ASA 81mg/esomeprazole 20mg<br>* Multiple doses administered on Day 1 to 5<br>|
| Active Comparator: 2<br>ASA (Acetylsalicylzuur Apotex cardio 80 mg) Tablet 80 mg | Drug: Acetylsalicylzuur Apotex Cardio<br>* Multiple doses administered on Day 1 to 5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, safety labs | No formal statistical tests will be performed. Abnormalities will be listed without statistical analysis | Pre-dose up to 7 day after last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetyl Salicylic Acid, Bioavailability, Healthy Volunteers