Clinical trial • Phase III • Other

bosentan for Healthy volunteer

Phase III trial of bosentan for Healthy volunteer. 16 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Healthy volunteer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
12-02-2026
First CTIS Authorization Date
15-04-2026

Trial design

Phase III trial across 1 site in Germany.

Target Sample Size
16
Trial Duration For Participant
52

Recruitment

Planned Sample Size
16
Recruitment Window Months
1

Geography

Total Number Of Sites
1
Total Number Of Participants
16

Germany

Earliest CTIS Part Ii Submission Date
10-04-2026
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
5
Number Of Sites
1
Number Of Participants
16

Sites

Site Name
Boehringer Ingelheim Pharma GmbH & Co. KG
Department Name
Global Clinical Development & Operations
Contact Person Name
Thomas Gießmann

Sponsor

Primary sponsor

Full Name
Boehringer Ingelheim International GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
bosentan
Active Substance
bosentan
Modality
Small molecule
Investigational Product Name
zongertinib
Active Substance
zongertinib
Modality
Small molecule

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