A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis

Summary

The objectives of this bioequivalence study in patients with ulcerative colitis (UC) were: * To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol Delayed Release Tablets 2.4 g per day (800 mg three times daily) and * To evaluate the safety of MDRT 2.4 g per day (800 mg three times daily) compared to placebo.

Timeline

Start

2008-01

Primary completion

2009-06

Completion

2009-08

Drugs

Indications