Clinical trial • Phase IV • Other

Paracetamol (acetaminophen) for Healthy volunteer

Phase IV trial of Paracetamol (acetaminophen) for Healthy volunteer. 48 participants.

Overview

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

Key dates

Initial CTIS Submission Date
29-07-2024
First CTIS Authorization Date
05-11-2024

Trial design

Phase IV trial in France.

Target Sample Size
48

Eligibility

Recruits 48 No vulnerable population selected (isVulnerablePopulationSelected:false).

Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected:false)

Recruitment

Planned Sample Size
48
Recruitment Window Months
48

Geography

Total Number Of Sites
1
Total Number Of Participants
48

France

Earliest CTIS Part Ii Submission Date
18-10-2024
Latest Decision Or Authorization Date
05-11-2024
Processing Time Days
18
Number Of Sites
1
Number Of Participants
48

Sites

Site Name
Service Hospitalier Frédéric Joliot - Commissariat à Energie Atomique
Department Name
service hospitalier Frédéric Joliot
Contact Person Name
Vincent Lebon
Contact Person Email
vincent.lebon@cea.fr
Number Of Participants
48

Sponsor

Primary sponsor

Full Name
Commissariat à l’Energie Atomique et aux Energies Alternatives
Organisation Type
Industry
Country Of Registered Address
France

Investigational products

Investigational Product Name
Paracetamol
Active Substance
Paracetamol (acetaminophen)
Modality
Small molecule

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