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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: May 30, 2008
Last updated: March 11, 2009
Last verified: March 2009
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

Condition Intervention Phase
Ulcers Upper GI Symptoms Drug: Esomeprazole 40mg/ASA 325mg Drug: Esomeprazole Drug: ASA Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Samples for measurement of esomeprazole, ASA, and SA concentrations [ Time Frame: Day 1 of each period ]

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

Estimated Enrollment: 84
Study Start Date: April 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
combination capsule of Esomeprazole 40mg + ASA 325mg
Drug: Esomeprazole 40mg/ASA 325mg
combination capsule, administered as a single oral dose
Other Name: Nexium/Bayer Aspirin
Experimental: 2
Esomeprazole 40 mg capsule and ASA 325 mg tablet
Drug: Esomeprazole
40mg capsule, administered as a single dose
Other Name: Nexium
Drug: ASA
325mg tablet, administered as a single oral dose
Other Name: Bayer aspirin


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00688428

Sponsors and Collaborators
Study Director: Jörgen Naesdal, M.D. AstraZeneca
Principal Investigator: Christopher Billings ., D.O Biokinetics Clinical Applications
  More Information

Responsible Party: Tore Lind, MD, Medical Science Director NEXIUM and GI Established Brands, AstraZeneca Pharmaceuticals Identifier: NCT00688428     History of Changes
Other Study ID Numbers: D961FC00002
Study First Received: May 30, 2008
Last Updated: March 11, 2009

Keywords provided by AstraZeneca:
upper gi symptoms
low dose Aspirin treatment

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors processed this record on August 22, 2017