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
- 28-05-2025
- First CTIS Authorization Date
- 01-09-2025
Trial design
Randomised, mesalamine delayed release tablets usp 1.2 g (test product) versus mezavant (mesalamine) delayed and extended-release tablets 1.2 g (reference product); single-dose, two-treatment, four-period, two-sequence, crossover study under fasting conditions (single 1.2 g dose stated).-controlled, crossover Phase II trial across 1 site in Romania.
- Randomised
- Yes
- Comparator
- Mesalamine Delayed Release Tablets USP 1.2 g (test product) versus Mezavant (mesalamine) Delayed and Extended-Release Tablets 1.2 g (reference product); single-dose, two-treatment, four-period, two-sequence, crossover study under fasting conditions (single 1.2 g dose stated).
- Crossover
- Yes
- Target Sample Size
- 112
Eligibility
Recruits 112 Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on vulnerable population considerations, consent or assent handling are provided in the available documents..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on vulnerable population considerations, consent or assent handling are provided in the available documents.
Recruitment
- Planned Sample Size
- 112
- Recruitment Window Months
- 6
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 112
Romania
- Earliest CTIS Part Ii Submission Date
- 12-06-2025
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 81
- 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 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 product of 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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