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
- 23-04-2025
- First CTIS Authorization Date
- 22-07-2025
Trial design
Randomised, mesalamine delayed release tablets usp 1.2 g (sun pharmaceutical industries limited) versus mezavant (mesalamine) delayed and extended-release tablets 1.2 g (takeda canada inc.), single-dose, fed condition, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence design-controlled, crossover Phase II trial across 1 site in Romania.
- Randomised
- Yes
- Comparator
- Mesalamine Delayed Release Tablets USP 1.2 g (Sun Pharmaceutical Industries Limited) versus Mezavant (mesalamine) Delayed and Extended-Release Tablets 1.2 g (Takeda Canada Inc.), single-dose, fed condition, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence design
- Crossover
- Yes
- Target Sample Size
- 168
Recruitment
- Planned Sample Size
- 168
- Recruitment Window Months
- 5
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 168
Romania
- Earliest CTIS Part Ii Submission Date
- 12-05-2025
- Latest Decision Or Authorization Date
- 22-07-2025
- Processing Time Days
- 71
- Number Of Sites
- 1
- Number Of Participants
- 168
Sites
- Site Name
- Terapia S.A. (Strada Fabricii Nr. 124, Cluj-Napoca)
- 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 Tablets USP 1.2 g (manufactured by Sun Pharmaceutical Industries Limited, India)
- Active Substance
- Mesalamine
- Modality
- Small molecule
- Routes Of Administration
- Oral (tablets)
- Route
- Oral
- Starting Dose
- 1.2 g
- Dose Levels
- Single-dose
- Frequency
- Single-dose
- Maximum Dose
- 1.2 g
- Investigational Product Name
- Mezavant (mesalamine) Delayed and Extended-Release Tablets 1.2 g (Takeda Canada Inc.)
- Active Substance
- Mesalamine
- Modality
- Small molecule
- Routes Of Administration
- Oral (tablets)
- Route
- Oral
- Starting Dose
- 1.2 g
- Dose Levels
- Single-dose
- Frequency
- Single-dose
- Maximum Dose
- 1.2 g
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