Clinical trial • Phase II • Other
Mirabegron for Healthy volunteers
Phase II trial of Mirabegron for Healthy volunteers. 54 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 30-01-2026
- First CTIS Authorization Date
- 16-02-2026
Trial design
Phase II trial across 1 site in Portugal.
- Target Sample Size
- 54
Recruitment
- Planned Sample Size
- 54
- Recruitment Window Months
- 2
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 54
Portugal
- Earliest CTIS Part Ii Submission Date
- 20-01-2026
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 54
Sites
- Site Name
- Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
- Department Name
- Medical Management
- Contact Person Name
- Suzana Cecatto
- Contact Person Email
- phase1@blueclinical.pt
Sponsor
Primary sponsor
- Full Name
- Laboratorios Cinfa S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- Mirabegron 50 mg Prolonged-Release Tablets
- Active Substance
- Mirabegron
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Starting Dose
- 50 mg
- Dose Levels
- 50 mg
- Maximum Dose
- 50 mg
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