Gastric residence time of mucoadhesive Minitablets
Conditions
Interventions
Group 1: After a 10-hour fasting phase overnight, morning intake of three newly developed mucoadhesive mini-tablets (Test, based on Carbopol 71 G NF, without active ingredient) in a Vcaps plus hard ca
Sponsors
Institut für Pharmazie, Biopharmazie & Pharmazeutische Technologie
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: - written informed consent (“Einverständniserklärung”) ICF must be obtained before any assessment is performed - age: 18 - 45 years - sex: male and female - ethnic origin: Caucasian - body mass index: 18.0 to 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 clinical relevant way from the normal state
Exclusion criteria
Exclusion criteria: - 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 and/or tablet materials - 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, 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 |
|---|---|
| Gastric residence time according to MRI within 4h | — |
Secondary
| Measure | Time frame |
|---|---|
| Ileal arrival according to MRI | — |
Countries
Germany
Contacts
Public ContactMichael Grimm
Institut für Pharmazie, Biopharmazie & Pharmazeutische Technologie
Outcome results
None listed