No diseases are examined directly. Examination of substances utilizable as salivary marker for gastrointestinal transit processes and comparison with established marker 13C3-caffeine.
Conditions
Interventions
Group 1: Intake of enteric coated Enprotect-capsules filled with up to 25 mg 13C3-caffeine, up to 100 mg methylliberine and up to 100 mg riboflavin (on an empty stomach with 240 ml water)
afterwards self-reliant collecting of saliva samples at the times t = -5, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 270, 285, 300, 315, 360, 375, 420, 435, 480, 600, 72
Sponsors
Institut für Pharmazie; Biopharmazie & Pharmazeutische Technologie
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: • BMI: >= 18 kg/m² und <= 30 kg/m² • minimum weight: 45 kg • good health as evidenced by the results of the physical examination, which are judged by the responsible physician not to differ in a clinically relevant way from the normal state • existence of written consent declaration
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 • known liver disease or functional disorder • 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 • 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 seriously • regular intake of vitamin supplements which contain vitamin B2 • known allergy or hypersensitivity to the compounds of the capsule (caffeine, methylliberine or riboflavin and foods containing these substances)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of the applied substances (13C3-caffeine, methylliberine, riboflavin) or their metabolites in saliva / urine over time measured by validated LC-MS/MS method or fluorimetric 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 & Pharmazeutische Technologie
Outcome results
None listed