NCT00600678

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
Last Updated

May 15, 2008

Status Verified

May 1, 2008

Enrollment Period

1 month

First QC Date

January 7, 2008

Last Update Submit

May 14, 2008

Conditions

Enteral Nutrition

Keywords

food for special medical purposes

Outcome Measures

Primary Outcomes (1)

  • - Gastric emptying after a single oral administration of a nutritional supplement

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

Secondary Outcomes (1)

  • safety and tolerability

    entire study

Study Arms (1)

1

EXPERIMENTAL
Dietary Supplement: ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)

Interventions

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

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

1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • caucasian origin
  • BMI: 22kg/m2 - 27kg/m2;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SocraTec R&D GmbH, Clinical Pharmacology Unit

Erfurt, Thuringia, 99084, Germany

Location

MeSH Terms

Interventions

Dietary SupplementsFood

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Frank Donath, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 25, 2008

Study Start

November 1, 2007

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

May 15, 2008

Record last verified: 2008-05

Locations

DE(1)