Conditions: Ulcerative Colitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 52
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: MMX Mesalamine intervention 2: MMX Mesalamine intervention 3: MMX Mesalamine
Intervention descriptions: intervention 1: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. intervention 2: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. intervention 3: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.

Protocol document: