The effect of posture on gastric emptying and pharmacokinetics of solid oral dosage forms
- Conditions
- Position dependence of the pharmacokinetics of different dosage forms, no disease/no health problem
- Registration Number
- DRKS00034434
- Lead Sponsor
- Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
*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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Comparison of PK between upright, supine, right decubitus and left decubitus position<br>Comparison between tablet, capsule and ice capsule within each treatment<br>Localization of dosage forms by use of MRI in different postures