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Gastric Emptying Study After Administration of a High Caloric Sip Feed

This study has been completed.
Sponsor:
Information provided by:
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT00600678
First received: January 7, 2008
Last updated: May 14, 2008
Last verified: May 2008
History of Changes
  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)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: 1 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
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: Frank Folchert, Fresenius Kabi Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00600678     History of Changes
Other Study ID Numbers: N-PRX-02-DE
Study First Received: January 7, 2008
Last Updated: May 14, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Fresenius Kabi:
food for special medical purposes

ClinicalTrials.gov processed this record on May 16, 2013