Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306391
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-05
Brief Title:
Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers
Sponsor:
Parc de Salut Mar
Organization:
Parc de Salut Mar
Study Overview
Official Title:
Physiologically Based Pharmacokinetic Modelling of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase I interventional clinical trial and the aim will be to characterize the PK and PD of two formulations of naloxone intranasal and intravenous in healthy subjects which will be used to verifyvalidate nasal-CNS-PBPK Physiologically Based Pharmacokinetic model predictions following intranasal dosing
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None