Study Comparing a Fixed-Dose Capsule of Esomeprazole 40mg and LDA 325mg With Free Combination
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ulcers; Low Dose Aspirin Treatment; Upper gi Symptoms
Intervention: Esomeprazole 40mg/ASA 325mg (Drug); Esomeprazole (Drug); ASA (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Jörgen Naesdal, M.D., Study Director, Affiliation: AstraZeneca
Christopher Billings ., D.O, Principal Investigator, Affiliation: Biokinetics Clinical Applications
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
Clinical Details
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
Study design: Other, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Samples for measurement of esomeprazole, ASA, and SA concentrations
Secondary outcome: Fasting blood samples for determination of clinical chemistry and hematology parametersurine samples for urinalysis parameters
Eligibility
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: April 2008
Ending date: November 2008
Last updated: June 2, 2008
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