Clinical trial • Phase III • Other

Clinical trial in Sedation | Healthy volunteer

Phase III trial for Sedation | Healthy volunteer. 40 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Sedation | Healthy volunteer
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
20-12-2024
First CTIS Authorization Date
31-03-2025

Trial design

Phase III trial across 1 site in Spain.

Target Sample Size
40

Eligibility

Recruits 40 Vulnerable populations not selected; no details on consent or assent provided..

Vulnerable Population
Vulnerable populations not selected; no details on consent or assent provided.

Recruitment

Planned Sample Size
40
Recruitment Window Months
23

Geography

Total Number Of Sites
1
Total Number Of Participants
40

Spain

Earliest CTIS Part Ii Submission Date
05-02-2025
Latest Decision Or Authorization Date
22-07-2025
Processing Time Days
167
Number Of Sites
1
Number Of Participants
40

Sites

Site Name
Hospital Del Mar
Department Name
Anesthesiology, Resuscitation and Pain Therapy Department
Contact Person Name
Juan Luis Fernández
Contact Person Email
jfernandezc@psmar.cat
Number Of Participants
40

Sponsor

Primary sponsor

Full Name
Consorci Mar Parc De Salut De Barcelona
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

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