Clinical trial • Phase II • Other
Indapamide
Phase II trial of Indapamide. 24 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 19-03-2026
- First CTIS Authorization Date
- 22-04-2026
Trial design
Phase II trial across 1 site in Portugal.
- Target Sample Size
- 24
Eligibility
Recruits 24 Vulnerable population selected: true (isVulnerablePopulationSelected). Clinical trial groups: Healthy volunteers. No details on consent or assent handling provided in the record..
- Vulnerable Population
- Vulnerable population selected: true (isVulnerablePopulationSelected). Clinical trial groups: Healthy volunteers. No details on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 2
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 24
Portugal
- Earliest CTIS Part Ii Submission Date
- 16-03-2026
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 37
- Number Of Sites
- 1
- Number Of Participants
- 24
Sites
- Site Name
- Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
- Department Name
- Medical Management
- Contact Person Name
- Paulo Alves Ferreira
- Contact Person Email
- phase1@blueclinical.pt
Sponsor
Primary sponsor
- Full Name
- Institut De Recherches Internationales Servier IRIS
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Indapamide SR 1.5 mg (film-coated mini-tablet)
- Active Substance
- Indapamide
- Modality
- Small molecule
- Routes Of Administration
- Oral (film-coated mini-tablet)
- Route
- Oral
- Starting Dose
- 1.5 mg
- Dose Levels
- 1.5 mg
- Frequency
- Single dose
- Investigational Product Name
- Indapamide IR 2.5 mg (film-coated tablet)
- Active Substance
- Indapamide
- Modality
- Small molecule
- Routes Of Administration
- Oral (film-coated tablet)
- Route
- Oral
- Starting Dose
- 2.5 mg
- Dose Levels
- 2.5 mg
- Frequency
- Single dose
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