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”

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.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole/ASA Fixed Combination
  • Capsule, oral, single dose
• Drug: Esomeprazole - Nexium
  • Clinical Trial Capsule or MUPS Tablet, oral, single dose
• Drug: ASA
  • Tablet, oral, single dose

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Esomeprazole 40 mg/ASA 325 mg Fixed Dose Combination Capsule
• Active Comparator: 2
  • Esomeprazole Clinical Trial Capsule 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg
• Active Comparator: 3
  • Esomeprazole MUPS Tablet 40 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg

Primary 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.
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

TJørgen Næsdal, MD, PhD Study Director AstraZeneca R&D  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00998075

Study ID Number: D961FC00007

ClinicalTrials.gov Identifier: NCT00998075

Health Authority: Canada: Health Canada