Gastric Emptying Study After Administration of a High Caloric Sip Feed - Full Text View

Purpose

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

Condition	Intervention
Enteral Nutrition	Dietary Supplement: ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)

MedlinePlus related topics:

Dietary Supplements

Drug Information available for:

Acetaminophen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label, Uncontrolled, Single Group Assignment

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

Further study details as provided by Fresenius Kabi:

Primary Outcome Measures:

- Gastric emptying after a single oral administration of a nutritional supplement [ Time Frame: Time frame gastric emptying: blood samples will be taken at predefined time points, up to 12h after application of test product. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety and tolerability [ Time Frame: entire study ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	November 2007
Study Completion Date:	January 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600678

Locations


Germany, Thueringen
	SocraTec R&D GmbH, Clinical Pharmacology Unit
	Erfurt, Thueringen, Germany, 99084

Sponsors and Collaborators

Fresenius Kabi

Investigators


Principal Investigator:	Frank Donath, MD	SocraTec R&D GmbH, Clinical Pharmacology Unit, Erfurt, Germany

More Information

Responsible Party:	Fresenius Kabi Deutschland GmbH ( Frank Folchert )
Study ID Numbers:	N-PRX-02-DE
First Received:	January 7, 2008
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00600678
Health Authority:	Germany: Ethics Commission

Keywords provided by Fresenius Kabi:

food for special medical purposes

Study placed in the following topic categories:

Healthy

Acetaminophen

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Fresenius Kabi
Information provided by:	Fresenius Kabi
ClinicalTrials.gov Identifier:	NCT00600678