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Gastric Emptying Study After Administration of a High Caloric Sip Feed

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00600678
First Posted: January 25, 2008
Last Update Posted: May 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Fresenius Kabi
  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: None (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:


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. ]

Secondary Outcome Measures:
  • safety and tolerability [ Time Frame: entire study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Frank Folchert, Fresenius Kabi Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00600678     History of Changes
Other Study ID Numbers: N-PRX-02-DE
First Submitted: January 7, 2008
First Posted: January 25, 2008
Last Update Posted: May 15, 2008
Last Verified: May 2008

Keywords provided by Fresenius Kabi:
food for special medical purposes