Investigation of esophageal transit and the swallowability of hard capsules
Conditions
Interventions
Group 1: intake of Hard gelatine capsule as reference (unmodified)
MRI 2min after capsule intake with 10 mL water
Group 2: intake of HPMC hard capsule
MRI 2min after capsule intake with 10 mL water
Gr
Sponsors
Institut für Pharmazie, Biopharmazie & Pharmazeutische Technologie
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: BMI: 18 – 30 kg/m² Signed written informed consent Good health as evidenced by the results of the inclusion anamnesis which does not to differ in a clinically relevant way from the normal state and does not implicate a disease requiring long-term medication.
Exclusion criteria
Exclusion criteria: ? Patients with dysphagia ? Patients with swallowing difficulties in respect to solid oral dosage forms which do not allow safe and reliable study participation ? Any contraindications to MRI imaging including, in particular, implants containing metal (except dental retainers), pacemakers, brain aneurysm clips, brain or pacemaker leads, implanted defilibrators, artificial heart valves, cochlear implants, foreign bodies in the eye, implanted insulin pumps, large and dark tattoos, and claustrophobia ? Known intolerance against any of the dosage form materials ? Alcohol and drug dependency ? Concomitant medication with drugs known to affect gastrointestinal function in particular: o Laxatives o Antidiarrheal o Prokinetics o Antiemetics o Medication with pronounced anticholinergic effects such as antidepressants or neuroleptics o Opioids o Antibiotics o Proton pump inhibitors, antacids, H2-antihistaminics o Calcium antagonists o Beta blockers o nitrates ? Gastrointestinal diseases and/or pathological changes that may interfere with the swallowing process ? History of orthostatic dysregulation or fainting (<1 year) ? Persons not being able to follow the instructions reliably ? Persons not being able to understand written or spoken instructions and indoctrinations regarding risks they are going to envisage ? Accommodation in an institute due to judicial order or regulatory action ? Participation in a clinical trial according to Arzneimittelgesetz, AMG, less than one month ago ? Eating disorders such as anorexia, bulimia ? Pregnant or breastfeeding persons ? Therapy with transdermal therapeutic systems ? Less then 7 days after full blood donation ? Less then 7 days after acute disease/infection ? Being in a state of dependence to study personnel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Esophageal retention rate (events/probands) 2 min after capsule ingestion determined by MRI to evaluate the influence of different shell materials, fillings and coatings on the probability of esophageal retention | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the subjective perception of the swallowability of capsules depending on their composition by means of a questionnaire; correlation between the objective MRI measurements of the esophageal transit of the capsules and the subjective evaluation of the swallowability of the capsules by the participants. | — |
Countries
Germany
Contacts
Public ContactMichael Grimm
Institut für Pharmazie, Biopharmazie & Pharmazeutische Technologie
Outcome results
None listed