A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis
Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
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.