Time point and localization of capsule disintegration in gastrointestinal tract
Conditions
Interventions
Group 1: Single intake of one coated hard capsule filled with caffeine and black iron oxide with 240 ml of water under fasting conditions. MRI imaging and collection of saliva samples over a period of
Sponsors
Institut für Pharmazie - Biopharmazie und Pharmazeutische Technologie
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy male and female volunteers aged 18 to 45 years, with Body Mass Index (BMI) between 18.0 and 29.9 kg/m²
Exclusion criteria
Exclusion criteria: Subjects fulfilling any of the following criteria are not eligible for inclusion in this study: • 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 • any contraindications for MRI including but not limited to the following: any metal bearing implants (excluding dental retainer), cardiac pacemakers, brain aneurysm clip, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body (e.g. metal shavings), implanted insulin pump, tattoos (as determined by imager) or claustrophobia • known allergic reactions or food intolerances to capsule materials or labelling agents • gastrointestinal diseases and/or pathological findings, which might interfere with gastrointestinal motility and emptying processes • drug or alcohol dependence • 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, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disintegration time and location of the hard capsule in the human gastrointestinal tract. t = 0 min corresponds to capsule intake. Measurement times: t = 15 min, 30 min, 45 min, 60 min, 75 min, 90 min, 105 min, 120 min, 135 min, 150 min, 165 min, 180 min ., 195 min, 210 min, 225 min, 240 min, 270 min, 300 min, 330 min, 360 min, 390 min, 420 min, 450 min, 480 min Measuring device: MAGNETOM Avanto (Siemens Healthcare, Erlangen, Germany) | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary endpoint evaluated. | — |
Countries
Germany
Contacts
Public ContactWerner Weitschies
Universität Greifswald
Outcome results
None listed