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Sponsored by: |
Fresenius Kabi |
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Information provided by: | Fresenius Kabi |
ClinicalTrials.gov Identifier: | NCT00600678 |
Measurement of gastric emptying time of an oral nutritional supplement (ProvideXtra DRINK) by using the paracetamol absorption method in healthy volunteers.
Condition | Intervention |
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Enteral Nutrition |
Dietary Supplement: ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes) |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label, Uncontrolled, Single Group Assignment |
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 |
Enrollment: | 12 |
Study Start Date: | November 2007 |
Study Completion Date: | January 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Dietary Supplement: ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)
Single, oral administration of nutritional supplement under fasting condition within 2 minutes.
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Germany, Thueringen | |
SocraTec R&D GmbH, Clinical Pharmacology Unit | |
Erfurt, Thueringen, Germany, 99084 |
Principal Investigator: | Frank Donath, MD | SocraTec R&D GmbH, Clinical Pharmacology Unit, Erfurt, Germany |
Responsible Party: | Fresenius Kabi Deutschland GmbH ( Frank Folchert ) |
Study ID Numbers: | N-PRX-02-DE |
Study First Received: | January 7, 2008 |
Last Updated: | May 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00600678 History of Changes |
Health Authority: | Germany: Ethics Commission |
food for special medical purposes |
Healthy Acetaminophen |