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

Ulcers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688428
• Other study ID #: D961FC00002
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2008
• Last updated: March 11, 2009
• Start date: April 2008
• Est. completion date: April 2008

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Ulcers
• Upper GI Symptoms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Samples for measurement of esomeprazole, ASA, and SA concentrations		Day 1 of each period	No
Secondary	Fasting blood samples for determination of clinical chemistry and hematology parameters		screening and follow up visit	Yes
Secondary	urine samples for urinalysis parameters		screening, Period 1, and follow-up visit	Yes