subjective and objective swallowability and acceptance of dosage forms
Conditions
Interventions
Group 1: Older participants (65 years or older): deglutition of four placebo tablets on three study days, swallowability evaluation of different solid oral dosage forms according to visual perception
Sponsors
Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Signed written informed consent. Adequate health-status allowing for appropriate study participation.
Exclusion criteria
Exclusion criteria: dementia, dysphagia, cognitive impaiments not allowing for adequate study participation, known intolerance against any of the dosage form materials, alcohol and drug dependency, persons not being able to follow the instructions reliably, participation in a clinical trial according to Arzneimittelgesetz less than one month ago, eating disorders, pregnant or breastfeeding persons, being in a state of dependence to study personnel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of swallowability, visual perception and handling of different solid oral dosage forms with self-developed questionnaires. Questionnaires are to be filled out after each study part. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of inter- and intraindividual variability in swallowing of tablets. Evaluation of differences between young and old study participants in respect to swallowability, visual perception and handling of the different solid oral dosage forms (young: 18 - 64 years, old: 65 years or older). | — |
Countries
Germany
Contacts
Public ContactWerner Weitschies
Institut für Pharmazie, Abteilung Biopharmazie und Pharmazeutische Technologie
Outcome results
None listed