MedDataX Logo

Gastric Emptying Study After Administration of a High Caloric Sip Feed

NCT ID: NCT00600678

Last Updated: 2008-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Enteral Nutrition

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

food for special medical purposes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)

Intervention Type DIETARY_SUPPLEMENT

Single, oral administration of nutritional supplement under fasting condition within 2 minutes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)

Single, oral administration of nutritional supplement under fasting condition within 2 minutes.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fresenius Kabi

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fresenius Kabi Deutschland GmbH

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Frank Donath, MD

Role: PRINCIPAL_INVESTIGATOR

SocraTec R&D GmbH, Clinical Pharmacology Unit, Erfurt, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SocraTec R&D GmbH, Clinical Pharmacology Unit

Erfurt, Thuringia, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N-PRX-02-DE

Identifier Type: -

Identifier Source: org_study_id