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Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)

NCT00749099 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2013-02-22

No results posted yet for this study

Summary

The overall purpose of this research is to demonstrate (or measure) the intestinal availability of lipase, amylase, and protease (enzymes the body has a shortage of) from PANCRECARB® when administered with a meal.

Conditions

  • Exocrine Pancreatic Insufficiency

Interventions

DRUG

pancrelipase

The test drug (PANCRECARB® \[pancrelipase\] - Phase II) with a standardized Lundh meal. Gastric samples are collect once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each).

DRUG

placebo

5 capsules of a placebo drug (Phase I) with a standardized Lundh meal. Gastric samples are collect once an hour and duodenal samples are collected every 15 minutes for each phase (4 hours each).

Sponsors & Collaborators

  • St. Louis University

    collaborator OTHER

  • Digestive Care, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2010-09-30
Completion
2010-09-30

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00749099 on ClinicalTrials.gov