DRKS00032726
Completed
未知
Study to investigate the influence of different coatings on the esophageal transit of tablets - MRI_EsoCoatings
Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie0 sites36 target enrollmentMarch 13, 2024
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie
- Enrollment
- 36
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 differ in a clinically relevant way from the normal state and does not implicate a disease requiring long\-term medication.
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
Outcomes
Primary Outcomes
Not specified
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