Trial intelligence / Profile preview

PK of Multiple Repeated Doses of Intranasal Naloxone

NCT04764630Phase 1Completed

Sponsor
Food and Drug Administration
Start
Mar 2021
Primary completion
Mar 2021
Modality
Orthosteric Ligands
Countries
1
01

Overview

Phase 1, randomised, open-label trial of naloxone in opioid overdose (3 arms), sponsored by Food and Drug Administration. Primary endpoints: First Timepoint When There is a Higher Naloxone Plasma Concentration in the 4 Naloxone Dose Arm (1 Every 2.5 Min) Compared to the 2 Naloxone Dose Arm (1 Every 2.5 Min) and First Timepoint When There is a Higher Naloxone Plasma Concentration in the 4 Naloxone Dose Arm (2 Doses Every 2.5 Min) Compared to the 2 Naloxone Dose Arm (1 Every 2.5 Min). Started Mar 2021; status: completed.

02

Drugs

naloxone
03

Conditions

opioid overdose

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