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

NCT00998075 | Completed Phase 1

• 1 other identifier: D961FC00007
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peptic Ulcer Disease

Keywords

Bioequivalence; ASA; Esomeprazole; peptic ulcer disease; primary cardiovascular protection; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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

  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.

Secondary Outcomes (1)

• 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

  PK samples to be taken for bioanalysis over a 24-hour period following dosing for each treatment arm

Study Arms (3)

1

ACTIVE COMPARATOR

Esomeprazole 40 mg/ASA 325 mg Fixed Dose Combination Capsule

Drug: Esomeprazole/ASA Fixed Combination

2

ACTIVE COMPARATOR

Esomeprazole Clinical Trial Capsule 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg

Drug: Esomeprazole - Nexium; Drug: ASA

3

ACTIVE COMPARATOR

Esomeprazole MUPS Tablet 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg

Drug: Esomeprazole - Nexium; Drug: ASA

Interventions

Esomeprazole/ASA Fixed Combination DRUG

Capsule, oral, single dose

1

Esomeprazole - Nexium DRUG

Clinical Trial Capsule or MUPS Tablet, oral, single dose

2; 3

ASA DRUG

Tablet, oral, single dose

Also known as: Aspirin

2; 3

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Scarborough Village, Ontario, Canada

Location

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Esomeprazole; Aspirin

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• TJørgen Næsdal, MD, PhD

  AstraZeneca R&D

  STUDY DIRECTOR

• Pierre Geoffroy, M.D. C.M., M.S

  Biovail Contract Research (BCR)a Division of Biovail Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 19, 2009
• First Posted: October 20, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 7, 2010

Record last verified: 2010-12

Locations

CA (1)