No diseases are investigated directly. We are looking for substances that are suitable as saliva markers for gastrointestinal transit processes and comparing them with the established marker caffeine.
Conditions
Interventions
Group 1: 1 coated tablet containing 25 mg caffeine and 100 mg methylliberin with 240 mL water after ingestion of a high-calorie (1000 kcal) FDA breakfast, independent saliva sample collection at the t
Sponsors
Institut für Pharmazie, Biopharmazie & Pharmazeutische Technologie
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: BMI between 18 kg/m² and 27 kg/m²
Exclusion criteria
Exclusion criteria: - Disorders/diseases affecting the swallowing process (e.g. severe dysphagia in relation to food and/or solid oral dosage forms) - 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) - 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 medication, especially medication that affects the function of the gastrointestinal tract - known allergy or hypersensitivity to caffeine or foods containing caffeine - known allergy or hypersensitivity to methyl liberin or foods containing methylliberine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the saliva concentration of the applied substances (caffeine, methyl liberin) or their metabolites over time using a validated LC-MS method | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters tmax, cmax, AUC, time of appearance of the analytes (tapp), elimination half-life (t1/2) | — |
Countries
Germany
Contacts
Public ContactWerner Weitschies
Institut für Pharmazie, Biopharmazie und Pharmazeutische Technologie
Outcome results
None listed