Overview

Pharmacokinetics of Intravenous and Intranasal Formulations of Naloxone in Healthy Volunteers.

Status:
COMPLETED
Trial end date:
2024-09-02
Target enrollment:
Participant gender:
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 verify/validate nasal-CNS-PBPK (Physiologically Based Pharmacokinetic) model predictions following intranasal dosing.
Phase:
PHASE1
Details
Lead Sponsor:
Parc de Salut Mar
Collaborator:
Food and Drug Administration (FDA)