Food Effect, Gastric Emptying Time, Gastrointestinal-transport, Magnetic Marker Monitoring, Small Intestinal Transit Time, Time for Colon Arrival
Conditions
Keywords
Imaging technique, gastric transport through the gut
Brief summary
The purpose of this study is to monitor the gastrointestinal transport of eroding gel matrix placebo tablets in healthy male volunteers under fasting and fed conditions. The method which is used is an imaging technique.
Interventions
DRUGD1000078
Oral, one single dose
DRUGD1000082
Oral, one single dose
DRUGD1000083
Oral, one single dose
DRUGD1000085
Oral, one single dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Ethnic origin: Caucasian * Body-mass index (BMI): ≥ 19 kg/m² and ≤ 27 kg/m² * Good health * Written informed consent, after having been informed about benefits and potential risks of the trial
Exclusion criteria
* Diseases which could influence the gastric emptying and gastrointestinal transport * Diet which could influence the gastric emptying and gastrointestinal transport * Surgery in the gastrointestinal tract which may interfere with the safety and transport of test product * Ferromagnetic implants or any other magnetic disturbance, which can affect the Magnetic Marker Monitoring measurement * Regular medical treatments which could affect the gastric emptying and gastrointestinal transport
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time from an administration of each of the placebo gel matrix tablets of each arm until Colon Arrival Time (CAT) | — |
| The time from an administration of each of the placebo gel matrix tablets of each arm until Gastric Emptying Time (GET) | — |
Countries
Germany
Outcome results
None listed