CLINICAL TRIALS PROFILE FOR APRISO

All Clinical Trials for APRISO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01327300 ↗	Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)	Completed	University of Florida	Phase 2	2010-03-01	The purpose of this study is to find whether treating patients with diarrhea predominant Irritable Bowel Syndrome (IBS) with an anti-inflammatory drug called Mesalamine will help improve their symptoms of diarrhea, bloating and abdominal pain.
NCT01999400 ↗	Correlation of Mesalamine Pharmacokinetics With Local Availability	Completed	Food and Drug Administration (FDA)	N/A	2012-04-01	This study is designed to provide data to the FDA correlating pharmacokinetics with local availability of medications within the gastrointestinal tract. This study will support the establishment of scientifically based standards for evaluating drugs which act locally within the gastrointestinal tract. Specific objectives of this study are to: (1) quantify how the plasma concentrations of mesalamine, an agent used to treat inflammatory bowel disease, are correlated with the concentrations in gastrointestinal fluids; and (2) improve the physiologically based models for drug absorption from the intestine. Information from this study in concert with in vitro dissolution data will be used to evaluate in vivo-in vitro correlation (IVIVC) for concentrations in plasma and intestinal lumen and dissolution of mesalamine products.
NCT01999400 ↗	Correlation of Mesalamine Pharmacokinetics With Local Availability	Completed	University of Michigan	N/A	2012-04-01	This study is designed to provide data to the FDA correlating pharmacokinetics with local availability of medications within the gastrointestinal tract. This study will support the establishment of scientifically based standards for evaluating drugs which act locally within the gastrointestinal tract. Specific objectives of this study are to: (1) quantify how the plasma concentrations of mesalamine, an agent used to treat inflammatory bowel disease, are correlated with the concentrations in gastrointestinal fluids; and (2) improve the physiologically based models for drug absorption from the intestine. Information from this study in concert with in vitro dissolution data will be used to evaluate in vivo-in vitro correlation (IVIVC) for concentrations in plasma and intestinal lumen and dissolution of mesalamine products.
NCT03327558 ↗	Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects	Completed	Bausch Health Americas, Inc.	Phase 1	2017-05-15	The objective of this study is to evaluate and compare the bioavailability of mesalamine
NCT03327558 ↗	Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects	Completed	Valeant Pharmaceuticals International, Inc.	Phase 1	2017-05-15	The objective of this study is to evaluate and compare the bioavailability of mesalamine

Clinical Trial Conditions for APRISO

Condition Name

Condition Name for APRISO
Intervention	Trials
Irritable Bowel Syndrome	1
Local Drug Concentration in Gastrointestinal Tract	1
Ulcerative Colitis	1

Condition MeSH

Condition MeSH for APRISO
Intervention	Trials
Colitis, Ulcerative	1
Syndrome	1
Irritable Bowel Syndrome	1
Diarrhea	1

Clinical Trial Locations for APRISO

Trials by Country

Trials by Country for APRISO
Location	Trials
United States	3

Trials by US State

Trials by US State for APRISO
Location	Trials
California	1
Michigan	1
Florida	1

Clinical Trial Progress for APRISO

Clinical Trial Phase

Clinical Trial Phase for APRISO
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for APRISO
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for APRISO

Sponsor Name

Sponsor Name for APRISO
Sponsor	Trials
Valeant Pharmaceuticals International, Inc.	1
University of Florida	1
Food and Drug Administration (FDA)	1

Sponsor Type

Sponsor Type for APRISO
Sponsor	Trials
Industry	2
Other	2
U.S. Fed	1