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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Peptic Ulcer Disease

Treatments: Drug: Esomeprazole/ASA Fixed Combination; Drug: Esomeprazole - Nexium; Drug: ASA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00998075

D961FC00007

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

138 participants in 3 patient groups

1

Active Comparator group

Description:

Esomeprazole 40 mg/ASA 325 mg Fixed Dose Combination Capsule

Treatment:

Drug: Esomeprazole/ASA Fixed Combination

2

Active Comparator group

Description:

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

Treatment:

Drug: ASA

Drug: Esomeprazole - Nexium

3

Active Comparator group

Description:

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

Treatment:

Drug: ASA

Drug: Esomeprazole - Nexium