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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00998075
First received: October 19, 2009
Last updated: December 6, 2010
Last verified: December 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Esomeprazole
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 August 28, 2014