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

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

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

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

No publications provided

Responsible Party:	Fresenius Kabi Deutschland GmbH ( Frank Folchert )
Study ID Numbers:	N-PRX-02-DE
Study First Received:	January 7, 2008
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00600678 History of Changes
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 May 06, 2009