No diseases are examined directly. Examination of substances utilizable as salivary marker for gastrointestinal transit processes and comparison with established marker caffeine
Conditions
Interventions
Group 1: 1 ice capsule caffeine 25 mg, fasted with 240 mL water, self-reliant salivary sampling at time points t = - 5, 4, 8, 12, 16, 20, 25, 30, 40, 50, 60, 90, 120, 180, 240, 360, 480, 600 and 1440
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 and <= 30 kg/m²
Exclusion criteria
Exclusion criteria: - Disorders/diseases affecting the swallowing process/difficulty swallowing larger monolithic dosage forms - gastrointestinal diseases and/or pathological changes that could interfere with gastric emptying -Known or suspected stenoses, fistulas or mechanical obstructions - obstructions within the gastrointestinal tract - Surgical interventions on the gastrointestinal tract within the last 12 months - Inflammatory bowel disease (Crohn's disease, ulcerative colitis or diverticulitis) - Known allergies or intolerances to the components of the standard meal or the vehicles administered (e.g. coeliac disease) - 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 in the last 12 months - People with dietary habits that affect gastrointestinal motility (vegetarians, vegans) - For women only: positive pregnancy test or gravidity - For women only: Breastfeeding - Known allergy or hypersensitivity to caffeine or foods containing caffeine - Persons who are known to be unwilling or unable to follow instructions reliably - Persons who are unable to understand written and verbal instructions and warnings regarding the study risks to which they are exposed - less than 14 days after acute illness - known allergy or hypersensitivity to theacrine and/or methylliberin or theacrine/ methylliberin-containing food
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of the applied substances (caffeine, theacrine, methylliberin) or their metabolites in saliva over time as measured by validated LC-MS/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 ContactMichael Grimm
Institut für Pharmazie; Biopharmazie & Pharmazeutische Technologie
Outcome results
None listed