Clinical trial • Phase II • Other

Loperamide for Healthy volunteers

Phase II trial of Loperamide for Healthy volunteers. 40 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Healthy volunteers
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
08-04-2026
First CTIS Authorization Date
29-04-2026

Trial design

Phase II trial across 1 site in Spain.

Target Sample Size
40

Recruitment

Planned Sample Size
40
Recruitment Window Months
1

Geography

Total Number Of Sites
1
Total Number Of Participants
40

Spain

Earliest CTIS Part Ii Submission Date
13-01-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
106
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Hospital Universitario De La Princesa
Department Name
Clinical Pharmacology Department
Contact Person Name
Dolores Ochoa
Number Of Participants
40

Sponsor

Primary sponsor

Full Name
Laboratorios Normon S.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Two formulations of loperamide
Active Substance
Loperamide
Modality
Small molecule

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