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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00998075

Collaborator

(none)

138

Enrollment

Location

Arms

Duration (Months)

46.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Peptic Ulcer Disease	Drug: Esomeprazole/ASA Fixed Combination Drug: Esomeprazole - Nexium Drug: ASA	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Esomeprazole 40 mg/ASA 325 mg Fixed Dose Combination Capsule	Drug: Esomeprazole/ASA Fixed Combination Capsule, oral, single dose
Active Comparator: 2 Esomeprazole Clinical Trial Capsule 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg	Drug: Esomeprazole - Nexium Clinical Trial Capsule or MUPS Tablet, oral, single dose Drug: ASA Tablet, oral, single dose Other Names: Aspirin
Active Comparator: 3 Esomeprazole MUPS Tablet 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg	Drug: Esomeprazole - Nexium Clinical Trial Capsule or MUPS Tablet, oral, single dose Drug: ASA Tablet, oral, single dose Other Names: Aspirin

Arm

Intervention/Treatment

Active Comparator: 1

Esomeprazole 40 mg/ASA 325 mg Fixed Dose Combination Capsule

Drug: Esomeprazole/ASA Fixed Combination

Capsule, oral, single dose

Active Comparator: 2

Esomeprazole Clinical Trial Capsule 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg

Drug: Esomeprazole - Nexium

Clinical Trial Capsule or MUPS Tablet, oral, single dose

Drug: ASA

Tablet, oral, single dose

Other Names:

Aspirin

Active Comparator: 3

Esomeprazole MUPS Tablet 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg

Drug: Esomeprazole - Nexium

Clinical Trial Capsule or MUPS Tablet, oral, single dose

Drug: ASA

Tablet, oral, single dose

Other Names:

Aspirin

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Scarborough	Ontario	Canada

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: TJørgen Næsdal, MD, PhD, AstraZeneca R&D
Principal Investigator: Pierre Geoffroy, M.D. C.M., M.S, Biovail Contract Research (BCR)a Division of Biovail Corporation