Status:

COMPLETED

Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free Combination

Lead Sponsor:

AstraZeneca

Conditions:

Ulcers

Upper GI Symptoms

Eligibility:

All Genders

20-50 years

Phase:

PHASE1

Brief Summary

The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet

Eligibility Criteria

Inclusion

  • Body mass index of 19-29kg/m2, inclusive
  • Weight of 50-95kg, inclusive
  • Clinically normal physical findings and laboratory values including hepatitis B, hepatitis C, and HIV, as judged by the Investigator

Exclusion

  • Significant clinical illness within the 2 weeks preceding the first dose of investigational products, as judged by the Investigator
  • History of mental, cardiac, renal, hepatitis, neurological, or significant gastrointestinal disease, as judged by the Investigator
  • Condition which could modify the absorption of the investigational products, as judged by the Investigator

Key Trial Info

Start Date :

April 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2008

Estimated Enrollment :

84 Patients enrolled

Trial Details

Trial ID

NCT00688428

Start Date

April 1 2008

End Date

April 1 2008

Last Update

March 12 2009

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