Application of saliva markers for the in vivo testing of dosage forms
- Conditions
- Determination of the gastric residence time of a new formulation compared to an established formulation
- Registration Number
- DRKS00031999
- Lead Sponsor
- Institut für Pharmazie - Biopharmazie & Pharmazeutische Technologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method c max, t max, AUC (0-120), AUC (0-360) from<br>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 Outcome Measures
Name Time Method MRI after 4h for evaluation of stomach filling and tablet integrity