Gastric Emptying Study After Administration of a High Caloric Sip Feed

May 14, 2008 updated by: Fresenius Kabi

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
- 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.
Time frame gastric emptying: blood samples will be taken at predefined time points, up to 12h after application of test product.

Secondary Outcome Measures

Outcome Measure
Time Frame
safety and tolerability
Time Frame: entire study
entire study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Kabi

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Estimate)

May 15, 2008

Last Update Submitted That Met QC Criteria

May 14, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • N-PRX-02-DE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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