DRKS00031999
Completed
未知
Application of saliva markers for the in vivo testing of dosage forms
Institut für Pharmazie - Biopharmazie & Pharmazeutische Technologie0 sites12 target enrollmentAugust 28, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Determination of the gastric residence time of a new formulation compared to an established formulation
- Sponsor
- Institut für Pharmazie - Biopharmazie & Pharmazeutische Technologie
- Enrollment
- 12
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ethnic origin: Caucasian
- •\-BMI: \> 18 kg/m² and \< 30 kg/m²
- •\-Minimum weight: 50 kg
- •\-Good health, judged by the investigator not to deviate from the norm in clinical terms
- •\-Presentation of written informed consent
Exclusion Criteria
- •\- Disorders/diseases affecting the swallowing process (e.g. severe dysphagia with regard to food and/or solid oral dosage forms).
- •\- claustrophobia
- •\- Gastrointestinal disease and/or pathological changes that may interfere with gastric emptying.
- •\- Known or suspected stenosis, fistulae or mechanical obstruction within the gastrointestinal tract.
- •\- surgical procedures on the gastrointestinal tract within the last 12 months
- •\- inflammatory bowel disease (Crohn's disease, ulcerative colitis or diverticulitis)
- •\- implanted or portable electromechanical medical devices such as a pacemaker, defibrillator or infusion pump
- •\- Known allergies or intolerances to the ingredients of the standard meal
- •\- Individuals who are unable to consume an appropriately sized portion of a meal in a given amount of time
- •\- Alcohol or drug addiction
Outcomes
Primary Outcomes
Not specified
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