Study Comparing Esomeprazole and Acetylsalicylic Acid (ASA) Combined Together as One Capsule Versus These Medications Taken Separately - Full Text View

Purpose

The purpose of this study is to investigate whether treatment with a combination capsule of Esomeprazole 40 mg and Aspirin (ASA) 325 mg is bioequivalent (i.e.has the same effect within the body) as these medications taken separately. Two different forms of esomeprazole (tablets and capsules) will be investigated.

Condition	Intervention	Phase
Peptic Ulcer Disease	Drug: Esomeprazole/ASA Fixed Combination Drug: Esomeprazole - Nexium 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-Centre, 3-Way Crossover Bioequivalence Study Comparing a Fixed Dose Combination Capsule of Esomeprazole 40 mg and Acetylsalicylic Acid 325 mg With Free Combinations of Esomeprazole Capsule 40 mg and Acetylsalicylic Acid Tablet 325 mg and Esomeprazole Tablet

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Aspirin Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Plasma concentration-time curve from time 0 to the last quantifiable concentration for esomeprazole administered as fixed dose combination (FDC) to esomeprazole administered as free combinations [ Time Frame: PK samples to be taken for bioanalysis over a 24-hour period following dosing on Day 1 of Period I and Day 1 of Period II and III. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics (PK): Total area under the plasma concentration-time curve (AUC0-inf), AUC0-t, Cmax, time to Cmax (Tmax), and half-life (t½) of esomeprazole [ Time Frame: PK samples to be taken for bioanalysis over a 24-hour period following dosing for each treatment arm ] [ Designated as safety issue: No ]

Enrollment:	138
Study Start Date:	September 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Esomeprazole 40 mg/ASA 325 mg Fixed Dose Combination Capsule	Drug: Esomeprazole/ASA Fixed Combination Capsule, oral, single dose
Active Comparator: 2 Esomeprazole Clinical Trial Capsule 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg	Drug: Esomeprazole - Nexium Clinical Trial Capsule or MUPS Tablet, oral, single dose Drug: ASA Tablet, oral, single dose Other Name: Aspirin
Active Comparator: 3 Esomeprazole MUPS Tablet 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg	Drug: Esomeprazole - Nexium Clinical Trial Capsule or MUPS Tablet, oral, single dose Drug: ASA Tablet, oral, single dose Other Name: Aspirin

Eligibility

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

Criteria

Inclusion Criteria:

Non-smoking male or female within the age range of 20 to 50 years
Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2

Exclusion Criteria:

Documented upper gastrointestinal surgery
Use of any proton pump inhibitors or any bismuth preparations (e.g. Pepto-Bismol®) within 14 days preceding the screening visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998075

Locations

Canada, Ontario
Research Site
Scarborough, Ontario, Canada

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	TJørgen Næsdal, MD, PhD	AstraZeneca R&D
Principal Investigator:	Pierre Geoffroy, M.D. C.M., M.S	Biovail Contract Research (BCR)a Division of Biovail Corporation

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00998075 History of Changes
Other Study ID Numbers:	D961FC00007
Study First Received:	October 19, 2009
Last Updated:	December 6, 2010
Health Authority:	Canada: Health Canada

Keywords provided by AstraZeneca:

Bioequivalence
ASA
Esomeprazole
peptic ulcer disease

primary cardiovascular protection
healthy volunteers
Primary cardiovascular protection

Additional relevant MeSH terms:

Peptic Ulcer
Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
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

ClinicalTrials.gov processed this record on May 22, 2013