Gastric Emptying Study After Administration of a High Caloric Sip Feed

Enteral Nutrition Clinical Trial

Official title:

Characterisation of Gastric Emptying of a High Caloric Sip Feed Using the Paracetamol Absorption Method: Intraindividual Comparison of Paracetamol Pharmacokinetics After Oral co-Administration With Sip-Feed and After Intravenous Administration in Healthy Volunteers of Both Genders in an Open, Single Centre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600678
• Other study ID #: N-PRX-02-DE
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: May 14, 2008
• Start date: November 2007
• Est. completion date: January 2008

Study information

• Verified date: May 2008
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Measurement of gastric emptying time of an oral nutritional supplement (ProvideXtra DRINK) by using the paracetamol absorption method in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Enteral Nutrition

Intervention

Dietary Supplement:
• ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)
Single, oral administration of nutritional supplement under fasting condition within 2 minutes.

Locations

Country	Name	City	State
Germany	SocraTec R&D GmbH, Clinical Pharmacology Unit	Erfurt	Thueringen

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- 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.	No
Secondary	safety and tolerability		entire study	No