Investigation of the contrast of manganese gluconate solution against food in the gastrointestinal tract.
Conditions
Interventions
Group 1: Ingestion of 240 ml of tap water labelled with manganese gluconate under fasted conditions.
Group 2: Ingestion of 240 ml of tap water mixed with manganese gluconate postprandially 30 min afte
Sponsors
Universität Greifswald, Institut für Pharmazie
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: BMI: > 18 kg/m² and < 30 kg/m² Weight: min. 50 kg Good health, assessed by the investigator as not deviating from the norm in clinical terms. Presence of written informed consent.
Exclusion criteria
Exclusion criteria: - Disorders/diseases affecting the swallowing process (e.g. severe dysphagia with regard to food and/or solid oral dosage forms). - claustrophobia - Gastrointestinal disease and/or pathological changes that may interfere with gastric emptying. - Known or suspected stenosis, fistulae or mechanical obstruction within the gastrointestinal tract. - diseases of the liver - Surgical procedures on the gastrointestinal tract within the last 12 months - inflammatory bowel disease (Crohn's disease, ulcerative colitis or diverticulitis) - Implanted or portable electromechanical medical devices such as a pacemaker, defibrillator or infusion pump - Tattoos - Known allergies or intolerances to the ingredients of meals - Persons who are unable to consume an appropriately sized portion of a meal in a given amount of time - Alcohol or drug addiction - Smokers with a cigarette consumption of more than 10 cigarettes per day - Eating disorders such as anorexia, bulimia - positive pregnancy test or gravidity - Persons who are known to be unwilling or unable to follow instructions reliably - Individuals who are unable to understand written and verbal instructions and warnings regarding the study risks they face - less than 14 days after acute illness - systemic use of medications, especially those that affect gastrointestinal function - known allergy or hypersensitivity to components of the dosage form During the study and for 4 weeks prior to the study, no medications that influence gastrointestinal motility and gastric function may be taken. Deviations from this rule are possible if there are at least 10 half-lives between the last intake of the drug and the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-dependent and absolute development of the contrast between manganese gluconate-laced fluid, surrounding tissue and food pulp. | — |
Secondary
| Measure | Time frame |
|---|---|
| Site-time evaluation of fluid in the gastrointestinal tract. | — |
Countries
Germany
Contacts
Public ContactWerner Weitschies
Universität Greifswald, Institut für Pharmazie
Outcome results
None listed