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OpenTrials
Completed

NCT Number: NCT00600678

Gastric Emptying Study After Administration of a High Caloric Sip Feed

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

Completed

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Key information

Conditions

Enteral Nutrition

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SocraTec R&D GmbH, Clinical Pharmacology Unit

Erfurt, Thuringia, 99084, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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

Dietary Supplement

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

Primary outcomes

  1. - 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.

Secondary outcomes

  1. safety and tolerability

    Time frame: entire study

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Jan 25, 2008
Registry last updated
May 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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