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Modernization of in vivo-in Vitro Oral Bioperformance Prediction and Assessment

NCT02806869 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-12-08

Study results available
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Summary

In vivo drug dissolution in the gastrointestinal (GI) tract is largely unmeasured. The purpose of this clinical study was to evaluate the in vivo drug dissolution and systemic absorption of the BCS Class IIa drug ibuprofen under fed and fasted conditions by direct sampling of stomach and small intestinal luminal content. Expanding current knowledge of drug dissolution in vivo will help to establish physiologically relevant in vitro models predictive of drug dissolution.

Conditions

  • Human Gastrointestinal Physiology Data

Interventions

DRUG

Single dose of ibuprofen (800 mg tablet)

DIETARY_SUPPLEMENT

Pulmocare, two 8.0 oz (236.6 mL) cans

Sponsors & Collaborators

Principal Investigators

  • Duxin Sun, Ph.D. · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-11-30
Completion
2017-07-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02806869 on ClinicalTrials.gov