Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free Combination

Official Title: “A Phase I, Open-Label, Randomized, Single-Center, 2-Stage Group Sequential Design, 2-Way Crossover Bioequivalence Study Comparing a Fixed-Dose Combination Capsule of Esomeprazole 40mg and Low-Dose Acetylsalicylic Acid (ASA) 325mg With a Free Combination of Esomeprazole Capsule 40mg and Low-Dose ASA”

The purpose of this study is to test if fixed dose esomeprazole and ASA capsule is pharmaceutically equal to a free combination of esomeprazole capsule and ASA tablet

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole 40mg/ASA 325mg
  • combination capsule, administered as a single oral dose
• Drug: Esomeprazole
  • 40mg capsule, administered as a single dose
• Drug: ASA
  • 325mg tablet, administered as a single oral dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • combination capsule of Esomeprazole 40mg + ASA 325mg
• Experimental: 2
  • Esomeprazole 40 mg capsule and ASA 325 mg tablet

Primary Measures

• Samples for measurement of esomeprazole, ASA, and SA concentrations
  • Time Frame: Day 1 of each period
    Safety Issue?: No

Secondary Measures

• Fasting blood samples for determination of clinical chemistry and hematology parameters
  • Time Frame: screening and follow up visit
    Safety Issue?: Yes
• urine samples for urinalysis parameters
  • Time Frame: screening, Period 1, and follow-up visit
    Safety Issue?: Yes

Inclusion Criteria:

• Body mass index of 19-29kg/m2, inclusive
• Weight of 50-95kg, inclusive
• Clinically normal physical findings and laboratory values including hepatitis B, hepatitis C, and HIV, as judged by the Investigator

Exclusion Criteria:

• Significant clinical illness within the 2 weeks preceding the first dose of investigational products, as judged by the Investigator
• History of mental, cardiac, renal, hepatitis, neurological, or significant gastrointestinal disease, as judged by the Investigator
• Condition which could modify the absorption of the investigational products, as judged by the Investigator

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 Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Jörgen Naesdal, M.D. Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00688428

Study ID Number: D961FC00002

ClinicalTrials.gov Identifier: NCT00688428

Health Authority: United States: Food and Drug Administration