healthy volunteers no medical condition, drug will be studied because they are known to influence gastric motility
Conditions
Interventions
Trade Name: Galvus
Pharmaceutical Form: Chewable tablet
Pharmaceutical form of the placebo: Chewable tablet
Route of administration of the placebo: Oral use
Sponsors
KULeuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: healthy volunteers (18-45) who have no bowel symptoms and who are on good general health are eligible for the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -they have relevant underlying disease (cardia, pulmonary, metabolic, kidney or liver desease....) -they have histoory of esophageal or gastric surgery, or recurrent or intermittent upper gastrointestinal symptoms (upper abdominal pain, nausea, vomiting, bothersome fullness or early satiation, heartburn, regurgitation...) -they have an history of allergy to several types of drugs or food -they have ever been treated for depression -there is possibility of becoming pregnant during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: we set out to investigate the effect of galvus on the relation between interdigestive motility and hunger peaks;Secondary Objective: none;Primary end point(s): 7 hours measurement;Timepoint(s) of evaluation of this end point: none | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none | — |
Countries
Belgium
Contacts
Public ContactJan Tack
KULeuven
Outcome results
None listed