Gastric Emptying Study After Administration of a High Caloric Sip Feed

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

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00600678

Enrollment

Registered

2008-01-25

Start date

2007-11-30

Completion date

2008-01-31

Last updated

2008-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Nutrition

Keywords

food for special medical purposes

Brief summary

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

Interventions

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

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	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

Measure	Time frame
safety and tolerability	entire study

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026