In vivo evaluation of press-coated tablets with caffeine for the determination of gastric water emptying in fasted and fed state and the influence of MEDCOAT®
- Conditions
- o disease was investigated
- Registration Number
- DRKS00032457
- 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
•written informed consent (Einverständniserklärung) ICF must be obtained before any assessment is performed
•BMI: <18.0 kg/m² and < 30 kg/m²
•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
•Current participation in any clinical study including the use of any investigational drugs at the time of enrolment, or within 5 half-lives of enrolment, whichever is longer; or longer if required by local regulations
•weight less than 45 kg
•known allergic reactions or food intolerance to the tablets or meals ingredients
•problems to swallow large tablets/capsules
•gastrointestinal diseases and/or pathological findings, which might interfere with gastrointestinal motility and emptying processes
•drug or alcohol addiction
•smokers of 10 or more cigarettes per day
•subjects who are on a diet which could affect gastrointestinal motility (vegetarian, vegan)
•eating disorders e.g. anorexia, bulimia
•heavy tea or coffee drinkers (more than 1L per day)
•lactating and pregnant women (positive urine test)
•subjects suspected or known not to follow instructions
•subjects who are unable to understand the written and verbal instructions, regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
•medical history of orthostatic dysregulation, fainting, or blackouts
•less than 2 weeks after last acute disease
•less than 1 week after last blood donation
•therapy with transdermal patches
•on the day of the study and for at least one week prior to it, do not take any medication that could affect the motility, function or secretion of the gastrointestinal tract, including: laxatives, antidiarrhoeal agents, prokinetic agents, antiemetics, medications with pronounced anticholinergic effects such as antidepressants or neuroleptics, opioids, antibiotics, proton pump inhibitors, antacids, H2 antihistamines, calcium antagonists, beta blockers, nitrates.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •To investigate if the press-coated tablet with caffeine is a suitable alternative to the ice capsule to detect the gastric water emptying by measurements of the caffeine concentration in saliva<br>•To investigate if the formulation is appropriate to detect the gastric water emptying in fasted and fed state<br>•To investigate if the caffeine pharmacokinetics of the tablets also represent slower gastric water emptying while using a maltodextrin solution, which slows down gastric emptying <br>•To study if the use of MEDCOAT® (for better swallowing and taste masking) influences the disintegration time of the oral formulation
- Secondary Outcome Measures
Name Time Method To evaluate whether the phenomenon of Magenstraße also appears in an upright position