Gastric Emptying Study After Administration of a High Caloric Sip Feed
Not Applicable
Completed
- Conditions
- Enteral Nutrition
- Interventions
- Dietary Supplement: ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)
- Registration Number
- NCT00600678
- Lead Sponsor
- Fresenius Kabi
- Brief Summary
Measurement of gastric emptying time of an oral nutritional supplement (ProvideXtra DRINK) by using the paracetamol absorption method in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- caucasian origin
- BMI: 22kg/m2 - 27kg/m2;
Exclusion Criteria
- existing diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of paracetamol (e.g. gastrointestinal or liver disease),
- known allergic reactions to investigational products,
- diseases and/or pathological findings, which could affect absorption, metabolism and/or gastric emptying (e.g. dyspepsia and gastroesophageal reflux),
- regular medication which can influence hepatic biotransformation and/or absorption,
- alcohol dependence, blood donation;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes) -
- Primary Outcome Measures
Name Time Method - Gastric emptying after a single oral administration of a nutritional supplement Time frame gastric emptying: blood samples will be taken at predefined time points, up to 12h after application of test product.
- Secondary Outcome Measures
Name Time Method safety and tolerability entire study
Trial Locations
- Locations (1)
SocraTec R&D GmbH, Clinical Pharmacology Unit
đŸ‡©đŸ‡ªErfurt, Thueringen, Germany