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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00688428
First received: May 30, 2008
Last updated: March 11, 2009
Last verified: March 2009
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688428

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

No publications provided

Responsible Party: Tore Lind, MD, Medical Science Director NEXIUM and GI Established Brands, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00688428     History of Changes
Other Study ID Numbers: D961FC00002
Study First Received: May 30, 2008
Last Updated: March 11, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Ulcer
Pathologic Processes
Aspirin
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014