Gastric Emptying Study After Administration of a High Caloric Sip Feed

Fresenius Kabi

Status: Completed

Conditions: Enteral Nutrition

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00600678

N-PRX-02-DE

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

1

Experimental group

Treatment:

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