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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00688428

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 I

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Acetylsalicylic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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

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:	August 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental combination capsule of Esomeprazole 40mg + ASA 325mg	Drug: Esomeprazole 40mg/ASA 325mg combination capsule, administered as a single oral dose
2: Experimental Esomeprazole 40 mg capsule and ASA 325 mg tablet	Drug: Esomeprazole 40mg capsule, administered as a single dose Drug: ASA 325mg tablet, administered as a single oral dose

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

Responsible Party:	AstraZeneca Pharmaceuticals ( Tore Lind, MD, Medical Science Director NEXIUM and GI Established Brands )
Study ID Numbers:	D961FC00002
Study First Received:	May 30, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00688428
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

esomeprazole
upper gi symptoms
low dose Aspirin treatment

Study placed in the following topic categories:

Aspirin
Ulcer
Omeprazole

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009