Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free Combination

Study Overview
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Brief Summary
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The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet

Official Title
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A Phase I, Open-Label, Randomized, Single-Center, 2-Stage Group Sequential Design, 2-Way Crossover Bioequivalence Study Comparing a Fixed-Dose Combination Capsule of Esomeprazole 40mg and Low-Dose Acetylsalicylic Acid (ASA) 325mg With a Free Combination of Esomeprazole Capsule 40mg and Low-Dose ASA

Conditions
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Ulcers, Upper GI Symptoms

Intervention / Treatment
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* Drug: Esomeprazole 40mg/ASA 325mg
* Drug: Esomeprazole
* Drug: ASA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index of 19-29kg/m2, inclusive Weight of 50-95kg, inclusive Clinically normal physical findings and laboratory values including hepatitis B, hepatitis C, and HIV, as judged by the Investigator Exclusion Criteria: Significant clinical illness within the 2 weeks preceding the first dose of investigational products, as judged by the Investigator History of mental, cardiac, renal, hepatitis, neurological, or significant gastrointestinal disease, as judged by the Investigator Condition which could modify the absorption of the investigational products, 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>combination capsule of Esomeprazole 40mg + ASA 325mg | Drug: Esomeprazole 40mg/ASA 325mg<br>* combination capsule, administered as a single oral dose<br>* Other names: Nexium/Bayer Aspirin;|
| Experimental: 2<br>Esomeprazole 40 mg capsule and ASA 325 mg tablet | Drug: Esomeprazole<br>* 40mg capsule, administered as a single dose<br>* Other names: Nexium;Drug: ASA<br>* 325mg tablet, administered as a single oral dose<br>* Other names: Bayer aspirin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Samples for measurement of esomeprazole, ASA, and SA concentrations |  | Day 1 of each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood samples for determination of clinical chemistry and hematology parameters |  | screening and follow up visit | 
| urine samples for urinalysis parameters |  | screening, Period 1, and follow-up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esomeprazole, upper gi symptoms, low dose Aspirin treatment