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

March 11, 2009 updated by: AstraZeneca

A Phase I, Open-Label, Randomized, Single-Center, 2-Stage Group Sequential Design, 2-Way Crossover Bioequivalence Study Comparing a Fixed-Dose Combination Capsule of Esomeprazole 40mg and Low-Dose Acetylsalicylic Acid (ASA) 325mg With a Free Combination of Esomeprazole Capsule 40mg and Low-Dose ASA

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
combination capsule of Esomeprazole 40mg + ASA 325mg
Drug: Esomeprazole 40mg/ASA 325mg
combination capsule, administered as a single oral dose
Other Names:
  • Nexium/Bayer Aspirin
Experimental: 2
Esomeprazole 40 mg capsule and ASA 325 mg tablet
Drug: Esomeprazole
40mg capsule, administered as a single dose
Other Names:
  • Nexium
Drug: ASA
325mg tablet, administered as a single oral dose
Other Names:
  • Bayer aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Samples for measurement of esomeprazole, ASA, and SA concentrations
Time Frame: Day 1 of each period
Day 1 of each period

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting blood samples for determination of clinical chemistry and hematology parameters
Time Frame: screening and follow up visit
screening and follow up visit
urine samples for urinalysis parameters
Time Frame: screening, Period 1, and follow-up visit
screening, Period 1, and follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Jörgen Naesdal, M.D., AstraZeneca
  • Principal Investigator: Christopher Billings ., D.O, Biokinetics Clinical Applications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 30, 2008

First Submitted That Met QC Criteria

June 2, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 11, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D961FC00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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