Study with young and healthy volunteers. No disease or health problem is being investigated. Basic physiological and biopharmaceutical study.
Conditions
Interventions
Group 1: Ingestion of 50 mL of water together with a labelled tablet and capsule 30 min after ingestion of a standardised light meal. Observation by MRI for 60 min and collection of saliva samples for
Sponsors
Universität Greifswald, Institut für Pharmazie
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Age: 18 - 55 years Gender: Male and female BMI: between 18 kg/m² and 27 kg/m² Minimum weight: 45 kg Good health, which is assessed by the investigator as not deviating from the norm in clinical terms Availability of the written declaration of consent
Exclusion criteria
Exclusion criteria: Disorders/diseases affecting the swallowing process (e.g. severe dysphagia in relation to food and/or solid oral dosage forms) claustrophobia gastrointestinal diseases and/or pathological changes that could interfere with gastric emptying known or suspected stenoses, fistulas or mechanical obstructions within the gastrointestinal tract Surgical interventions on the gastrointestinal tract within the last 12 months active inflammatory bowel disease (Crohn's disease, ulcerative colitis or diverticulitis) implanted or portable electromechanical medical devices such as pacemakers, defibrillators or infusion pumps Large dark tattoos Known allergies or intolerances to the components of the standard meal People who are unable to consume an appropriately sized portion of a meal in the specified time Alcohol or drug addiction Smokers with a cigarette consumption of more than 10 cigarettes per day Heavy tea or coffee drinkers (more than 1 litre per day) Eating disorders such as anorexia, bulimia Positive pregnancy test or pregnancy People who are known to be unwilling or unable to follow instructions reliably Persons who are unable to understand written and verbal instructions and instructions regarding the study risks they face less than 14 days after acute illness systemic intake of medications, especially those that affect the function of the gastrointestinal tract known allergy or hypersensitivity to caffeine or foods containing caffeine known allergy or hypersensitivity to theobromine or foods containing theobromine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of gastric emptying of 50, 100 and 150 mL of water in the postprandial state by volumetrisation of the gastric volume using MRI images at the times -6, 4, 8, 12, 16, 20, 30, 40, 50 and 58 min and evaluation of the salivary caffeine concentration at the times -5, 5, 9, 13, 17, 21, 31, 41, 51, 59, 65, 69, 73, 77, 81, 91, 101, 111 and 119 min using LC-MS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of methods for determining gastric emptying and distribution behaviour from the dosage forms between MRI vs. saliva markers using statistical descriptive methods. | — |
Countries
Germany
Contacts
Public ContactWerner Weitschies
Universität Greifswald, Institut für Pharmazie
Outcome results
None listed