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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