Gastric Emptying Study After Administration of a High Cal... | NCT00600678

Studies
Gastric Emptying Study After Administration of a High Caloric Sip Feed

NCT00600678

Sponsor

Fresenius Kabi

Status

Completed

Last Update Posted

May 15, 2008Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Enteral Nutrition

Interventions

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

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Jan 2008Actual

First Submitted Date

Jan 7, 2008

First Submission Date that Met QC Criteria

Jan 15, 2008

First Posted Date

Jan 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2008

Last Update Posted Date

May 15, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Dietary Supplement: ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)	Dietary Supplement	Single, oral administration of nutritional supplement under fasting condition within 2 minutes.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- 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

Measure	Description	Time Frame
safety and tolerability		entire study

Other Outcomes

Not provided

Eligibility Module

Eligibility 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;

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank Donath, MD	SocraTec R&D GmbH, Clinical Pharmacology Unit, Erfurt, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SocraTec R&D GmbH, Clinical Pharmacology Unit		Erfurt	Thuringia	99084	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D019587	Dietary Supplements
D005502	Food

Ancestor Terms

ID	Term
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided