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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688428
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : March 12, 2009
Information provided by:

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

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
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
Study Start Date : April 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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

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

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00688428

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

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
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: March 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