Study Comparing Esomeprazole and Acetylsalicylic Acid (ASA) Combined Together as One Capsule Versus These Medications Taken Separately

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether treatment with a combination capsule of Esomeprazole 40 mg and Aspirin (ASA) 325 mg is bioequivalent (i.e.has the same effect within the body) as these medications taken separately. Two different forms of esomeprazole (tablets and capsules) will be investigated.

Official Title
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A Phase I, Open-Label, Randomized, Single-Centre, 3-Way Crossover Bioequivalence Study Comparing a Fixed Dose Combination Capsule of Esomeprazole 40 mg and Acetylsalicylic Acid 325 mg With Free Combinations of Esomeprazole Capsule 40 mg and Acetylsalicylic Acid Tablet 325 mg and Esomeprazole Tablet

Conditions
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Peptic Ulcer Disease

Intervention / Treatment
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* Drug: Esomeprazole/ASA Fixed Combination
* Drug: Esomeprazole - Nexium
* Drug: ASA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-smoking male or female within the age range of 20 to 50 years Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2 Exclusion Criteria: Documented upper gastrointestinal surgery Use of any proton pump inhibitors or any bismuth preparations (e.g. Pepto-Bismol®) within 14 days preceding the screening visit

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 |
| --- | --- |
| Active Comparator: 1<br>Esomeprazole 40 mg/ASA 325 mg Fixed Dose Combination Capsule | Drug: Esomeprazole/ASA Fixed Combination<br>* Capsule, oral, single dose<br>|
| Active Comparator: 2<br>Esomeprazole Clinical Trial Capsule 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg | Drug: Esomeprazole - Nexium<br>* Clinical Trial Capsule or MUPS Tablet, oral, single dose<br>Drug: ASA<br>* Tablet, oral, single dose<br>* Other names: Aspirin;|
| Active Comparator: 3<br>Esomeprazole MUPS Tablet 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg | Drug: Esomeprazole - Nexium<br>* Clinical Trial Capsule or MUPS Tablet, oral, single dose<br>Drug: ASA<br>* Tablet, oral, single dose<br>* Other names: Aspirin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration-time curve from time 0 to the last quantifiable concentration for esomeprazole administered as fixed dose combination (FDC) to esomeprazole administered as free combinations |  | PK samples to be taken for bioanalysis over a 24-hour period following dosing on Day 1 of Period I and Day 1 of Period II and III. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Total area under the plasma concentration-time curve (AUC0-inf), AUC0-t, Cmax, time to Cmax (Tmax), and half-life (t½) of esomeprazole |  | PK samples to be taken for bioanalysis over a 24-hour period following dosing for each treatment arm | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, ASA, Esomeprazole, peptic ulcer disease, primary cardiovascular protection, healthy volunteers