Pharmacokinetics of IBD98-M 400mg-57.5/Day in Healthy Volunteers
Completed
Holy Stone Healthcare Co., Ltd
Phase 1
2014-07-01
The primary objective of this study is to compare the rate and extent of absorption of
mesalamine-sodium hyaluronate 200 mg-28.75 mg delayed-release capsule (IBD98-M, Test) versus
Delzicol 400 mg delayed-release capsule (mesalamine Reference), administered as a single oral
dose of 2 x 200 mg-28.75 mg delayed-release capsule (total dose of 400 mg-57.50 mg) or 1 x
400 mg delayed-release capsule under fasting conditions.
A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis
Not yet recruiting
AbbVie
Phase 3
2022-05-05
Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) characterized by
diffuse, continuous inflammation of the colon. This study will assess how safe and effective
mesalamine delayed-release capsules are in treating pediatric participants with UC. Adverse
events and change in disease activity will be assessed.
Delzicol (Mesalamine) is an approved drug being developed for the treatment of Ulcerative
Colitis (UC). Study doctors put the participants in 1 of 2 groups, called treatment arms.
Each group receives a different treatment. Around 80 Pediatric participants aged 5 to 17
years with a diagnosis of UC will be enrolled in approximately 45 sites in the United States.
Participants will receive oral mesalamine capsules twice daily for 26 weeks and followed for
30 days.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and completing questionnaires.
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