Clinical trial • Phase II • Other
Indapamide for Healthy volunteers
Phase II trial of Indapamide for Healthy volunteers.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Healthy volunteers
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 11-03-2026
- First CTIS Authorization Date
- 20-04-2026
Trial design
One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg versus One Film-Coated Tablet of Indapamide SR 1.5 mg; One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg versus One Film-Coated Tablet of Indapamide IR 2.5 mg.-controlled Phase II trial across 1 site in Portugal.
- Comparator
- One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg versus One Film-Coated Tablet of Indapamide SR 1.5 mg; One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg versus One Film-Coated Tablet of Indapamide IR 2.5 mg.
- Target Sample Size
- 48
Recruitment
- Planned Sample Size
- 48
- Recruitment Window Months
- 2
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 48
Portugal
- Earliest CTIS Part Ii Submission Date
- 09-03-2026
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 42
- Number Of Sites
- 1
- Number Of Participants
- 48
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
- One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg
- Active Substance
- Indapamide
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- oral
- Starting Dose
- 1.5 mg
- Investigational Product Name
- One Film-Coated Tablet of Indapamide SR 1.5 mg
- Active Substance
- Indapamide
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- oral
- Starting Dose
- 1.5 mg
- Investigational Product Name
- One Film-Coated Tablet of Indapamide IR 2.5 mg
- Active Substance
- Indapamide
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- oral
- Starting Dose
- 2.5 mg
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