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OpenTrials
Completed

NCT Number: NCT00688428

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

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

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Key information

Conditions

Ulcers Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcer Upper GI Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole 40mg/ASA 325mg

Drug

combination capsule, administered as a single oral dose

Other names: Nexium/Bayer Aspirin

Esomeprazole

Drug

40mg capsule, administered as a single dose

Other names: Nexium

ASA

Drug

325mg tablet, administered as a single oral dose

Other names: Bayer aspirin

Primary outcomes

  1. Samples for measurement of esomeprazole, ASA, and SA concentrations

    Time frame: Day 1 of each period

Secondary outcomes

  1. Fasting blood samples for determination of clinical chemistry and hematology parameters

    Time frame: screening and follow up visit

  2. urine samples for urinalysis parameters

    Time frame: screening, Period 1, and follow-up visit

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 3, 2008
Registry last updated
Mar 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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