Overview

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

Status:
Completed

Trial end date:
2017-07-01

Target enrollment:

Participant gender:

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.

Phase:

N/A

Details

Lead Sponsor:

University of Michigan

Collaborator:

Food and Drug Administration (FDA)

Treatments:

Ibuprofen