in vivo disintegration of oral dosage forms
Conditions
Interventions
Group 1: Administration of the reference capsule Capsugel® Enprotect® (HPMCAS grade H) and the test capsule Capsugel® Enprotect® (HPMCAS grade L).
Group 2: Administration of the reference capsule Caps
Sponsors
Institut für Pharmazie, Biopharmazie & Pharmazeutische Technologie
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: body mass index: > 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
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 materials or labelling agents (e.g. mannitol) • 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 • no medication is allowed that might interfere with gastrointestinal motility, function or secretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time point and gastrointestinal region of capsule disintegration as visible in MRI | — |
Secondary
| Measure | Time frame |
|---|---|
| Time point of capsule disintegration as detectable by caffeine appearance in saliva | — |
Countries
Germany
Contacts
Public ContactMichael Grimm
Institut für Pharmazie, Biopharmazie & Pharmazeutische Technologie
Outcome results
None listed