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

NCT00688428 | Completed Phase 1

• 1 other identifier: D961FC00002
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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

Conditions

Ulcers; Upper GI Symptoms

Keywords

esomeprazole; upper gi symptoms; low dose Aspirin treatment

Outcome Measures

Primary Outcomes (1)

• Samples for measurement of esomeprazole, ASA, and SA concentrations

  Day 1 of each period

Secondary Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

combination capsule of Esomeprazole 40mg + ASA 325mg

Drug: Esomeprazole 40mg/ASA 325mg

2

EXPERIMENTAL

Esomeprazole 40 mg capsule and ASA 325 mg tablet

Drug: Esomeprazole; Drug: ASA

Interventions

Esomeprazole 40mg/ASA 325mg DRUG

combination capsule, administered as a single oral dose

Also known as: Nexium/Bayer Aspirin

1

Esomeprazole DRUG

40mg capsule, administered as a single dose

Also known as: Nexium

2

ASA DRUG

325mg tablet, administered as a single oral dose

Also known as: Bayer aspirin

2

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Ulcer

Interventions

Esomeprazole; Aspirin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jörgen Naesdal, M.D.

  AstraZeneca

  STUDY DIRECTOR

• Christopher Billings ., D.O

  Biokinetics Clinical Applications

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 3, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: March 12, 2009

Record last verified: 2009-03