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

Phase 1

Completed

• Conditions: Ulcers; Upper GI Symptoms
• Interventions: Drug: Esomeprazole 40mg/ASA 325mg; Drug: Esomeprazole; Drug: ASA

• Registration Number: NCT00688428
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-11
• Last Update Posted: 2009-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Esomeprazole 40mg/ASA 325mg	combination capsule of Esomeprazole 40mg + ASA 325mg
2	Esomeprazole	Esomeprazole 40 mg capsule and ASA 325 mg tablet
2	ASA	Esomeprazole 40 mg capsule and ASA 325 mg tablet

Primary Outcome Measures

Name	Time	Method
Samples for measurement of esomeprazole, ASA, and SA concentrations	Day 1 of each period

Secondary Outcome Measures

Name	Time	Method
Fasting blood samples for determination of clinical chemistry and hematology parameters	screening and follow up visit
urine samples for urinalysis parameters	screening, Period 1, and follow-up visit