Gastroesophageal Reflux Disease
Conditions
Keywords
Reflux Inhibitor, GERD, PPI Interaction
Brief summary
The purpose of the study is to evaluate if AZD3355 and Nexium interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.
Interventions
DRUGAZD3355
150 mg bid, oral, 7 days
DRUGEsomeprazole
40 mg od, oral, 7 days
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of written informed consent * Females no childbearing potential * Clinically normal physical findings
Exclusion criteria
* Clinically significant illness within 2 weeks prior to the first dose of investigational product * History of clinically significant disease * Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK variables | Frequent sampling occasions during day 7 each treatment period |
Secondary
| Measure | Time frame |
|---|---|
| 4-BOH cholesterol | Sampling occasions during day 7 one treatment period (AZD3355 alone) |
| Safety variables (adverse events, blood pressure, pulse, safety lab) | During the whole treatment period |
Countries
Sweden
Outcome results
None listed