Position dependence of the pharmacokinetics of different dosage forms, no disease/no health problem
Conditions
Interventions
Group 1: Ingestion of a tablet, an hard gelatine capsule and an ice capsule each containing 25 mg isotope-labelled caffeine together with 240 mL tap water in upright position after a 10-hour fasting p
Sponsors
Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: * Ethnic origin: Caucasian * BMI: min. 18 kg/m² and max. 30 kg/m² * minimum weight: 50 kg * good state of health, which is assessed by the investigator as clinically not deviating from the norm in clinical terms * signed written informed consent
Exclusion criteria
Exclusion criteria: - Disorders/diseases affecting the swallowing process (e.g. severe dysphagia in relation to food and/or solid oral dosage forms) - claustrophobia - 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 - inflammatory bowel disease (Crohn's disease, ulcerative colitis or diverticulitis) - implanted or portable electromechanical medical devices such as pacemakers, defibrillators or infusion pumps - Large dark tattoos - Known allergies or intolerances to the components of the standard meal or the administered vehicles (especially caffeine, lactose) - 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) - Positive pregnancy test or pregnancy - Persons 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 medications (except contrazeptives), especially those that affect the function of the gastrointestinal tract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of differently isotope-labelled caffeine with regards to cmax, tmax, and AUC (0-60min) as measured by validated LC-MS/MS method in salivary probes | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of PK between upright, supine, right decubitus and left decubitus position Comparison between tablet, capsule and ice capsule within each treatment Localization of dosage forms by use of MRI in different postures | — |
Countries
Germany
Contacts
Public ContactWerner Weitschies
Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie
Outcome results
None listed