Determination of the gastric residence time of a new formulation compared to an established formulation
Conditions
Interventions
Group 1: Ingestion of a matrix tablet with 240 mL of tap water postprandially 30 min after the start of ingestion of a standardised high-caloric breakfast
Group 2: Ingestion of effervescent granules a
Sponsors
Institut für Pharmazie - Biopharmazie & Pharmazeutische Technologie
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: -Ethnic origin: Caucasian -BMI: > 18 kg/m² and < 30 kg/m² -Minimum weight: 50 kg -Good health, judged by the investigator not to deviate from the norm in clinical terms -Presentation 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. - 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 the standard meal - Individuals 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 - Heavy tea or coffee drinkers (more than 1 litre per day) - Eating disorders such as anorexia, bulimia - Positive pregnancy test or gravidity - People 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 caffeine or foods containing caffeine - Intolerance to lactose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| c max, t max, AUC (0-120), AUC (0-360) from salivary caffeine concentration at time points 2.5, 5, 15, 15, 20, 25, 30 min and onwards every 15 min until 6h, measured by validated LC-MS/MS | — |
Secondary
| Measure | Time frame |
|---|---|
| MRI after 4h for evaluation of stomach filling and tablet integrity | — |
Countries
Germany
Contacts
Public ContactWerner Weitschies
Institut für Pharmazie - Biopharmazie & Pharmazeutische Technologie
Outcome results
None listed