Clinical trial • Phase II • Gastroenterology
Mesalamine for Ulcerative colitis
Phase II trial of Mesalamine for Ulcerative colitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 28-02-2025
- First CTIS Authorization Date
- 25-06-2025
Trial design
Randomised, open-label, test product: mesalamine delayed release capsules 400 mg manufactured by sun pharmaceutical industries limited; comparator/reference product: mesalamine delayed-release capsules 400 mg, manufactured for teva pharmaceuticals usa, inc.; single-dose, fed condition, two-treatment, four-period, two-sequence fully replicate crossover design-controlled, crossover Phase II trial across 1 site in Romania.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Test product: Mesalamine delayed release capsules 400 mg manufactured by Sun Pharmaceutical Industries Limited; Comparator/reference product: Mesalamine Delayed-Release Capsules 400 mg, manufactured for Teva Pharmaceuticals USA, Inc.; single-dose, fed condition, two-treatment, four-period, two-sequence fully replicate crossover design
- Crossover
- Yes
- Target Sample Size
- 112
Recruitment
- Planned Sample Size
- 112
- Recruitment Window Months
- 3
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 112
Romania
- Earliest CTIS Part Ii Submission Date
- 21-02-2025
- Latest Decision Or Authorization Date
- 25-06-2025
- Processing Time Days
- 124
- Number Of Sites
- 1
- Number Of Participants
- 112
Sites
- Site Name
- Terapia S.A.
- Department Name
- Clinical Pharmacology and Pharmacokinetics
- Contact Person Name
- Elena Timofte
- Contact Person Email
- Elena.Timofte@sunpharma.com
Sponsor
Primary sponsor
- Full Name
- Sun Pharmaceutical Industries Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- India
Investigational products
- Investigational Product Name
- Mesalamine delayed release capsules 400 mg (manufactured by Sun Pharmaceutical Industries Limited)
- Active Substance
- Mesalamine
- Modality
- Small molecule
- Routes Of Administration
- oral (capsule)
- Route
- oral
- Starting Dose
- 400 mg
- Dose Levels
- 400 mg
- Frequency
- single-dose
- Investigational Product Name
- Mesalamine Delayed-Release Capsules 400 mg (manufactured for Teva Pharmaceuticals USA, Inc.)
- Active Substance
- Mesalamine
- Modality
- Small molecule
- Routes Of Administration
- oral (capsule)
- Route
- oral
- Starting Dose
- 400 mg
- Dose Levels
- 400 mg
- Frequency
- single-dose
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