Study comparing Esomeprazole and Acetylsalicylic Acid (ASA) combined together as one capsule versus these medications taken separately

Study identifier:D961FC00007

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Peptic ulcer disease

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Esomeprazole/ASA Fixed Combination, Esomeprazole - Nexium, ASA

Sex

All

Actual Enrollment

138

Study type

Interventional

Age

20 Years - 50 Years

Date

Study Start Date: 01 Sept 2009

Primary Completion Date: 01 Dec 2009

Study Completion Date: 01 Dec 2009

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Scarborough, Ontario, Canada

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

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=694&filename=CSR-D961FC00007.pdf
Download
CSR-D961FC00007.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Biovail Contract Research

1-866-207-3333

Investigators

Principal Investigator

TJørgen Næsdal

AstraZeneca R&D