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

Phase 1 Completed 8 enrolled Parc de Salut Mar Food and Drug Administration (FDA) · collab

RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start: 2024-03-05
Primary completion: 2024-05-13
Completion: 2024-09-02

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naloxone	Small molecule	1 mg	Intravenous
Subject	Naloxone	Small molecule	1.8 mg	Intravenous

Indications

No indication recorded.