NCT00998075

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Peptic Ulcer Disease

Interventions

Type	Name	Description
DRUG	Esomeprazole/ASA Fixed Combination	Capsule, oral, single dose
DRUG	Esomeprazole - Nexium	Clinical Trial Capsule or MUPS Tablet, oral, single dose
DRUG	ASA	Tablet, oral, single dose

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-10-20
• Last updated: 2010-12-07

Locations

1 site across 1 country: Canada