NCT00688428

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Ulcers
• Upper GI Symptoms

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2008-06-03
• Last updated: 2009-03-12