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Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects

Ulcerative Colitis Clinical Trial

Official title:
Full-replicate Study of APRISO 375 mg Extended-release Capsules Versus the Approved APRISO 375 mg Extended-release Capsules in Healthy Male and Female Subjects

Clinical Trial Summary

The objective of this study is to evaluate and compare the bioavailability of mesalamine

Clinical Trial Description

The objective of this study is to evaluate and compare the bioavailability of mesalamine and therefore to assess the bioequivalence of 375 mg APRISOTM extended-release capsule manufactured at a new site versus the approved 375 mg APRISOTM extended-release capsule after a single oral dose administration under fasting conditions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03327558
Study type Interventional
Source Valeant Pharmaceuticals International, Inc.
Contact
Status Completed
Phase Phase 1
Start date May 15, 2017
Completion date August 18, 2017
View Details
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