Ulcers, Upper GI Symptoms
Conditions
Keywords
esomeprazole, upper gi symptoms, low dose Aspirin treatment
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
Interventions
DRUGEsomeprazole 40mg/ASA 325mg
combination capsule, administered as a single oral dose
DRUGEsomeprazole
40mg capsule, administered as a single dose
DRUGASA
325mg tablet, administered as a single oral dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Samples for measurement of esomeprazole, ASA, and SA concentrations | Day 1 of each period |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed