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

NCT00998075 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2010-12-07

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • TJørgen Næsdal, MD, PhD · AstraZeneca R&D

  • Pierre Geoffroy, M.D. C.M., M.S · Biovail Contract Research (BCR)a Division of Biovail Corporation

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00998075 on ClinicalTrials.gov