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
  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:


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 April 16, 2014