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

NCT06306391 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-05-06

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Intravenous naloxone

Nyoxid 1.8 mg nasal spray, solution in single-dose container. Study drugs (naloxone nasal spray and naloxone intravenously) will be administered in 8 subjects in two sequences in fasting conditions (10 hours pre-dose and 4 hours post dose): Intranasal -\> washout period -\>intravenous (n=4) and Intravenous -\>washout period -\> intranasal (n=4).

DRUG

Intranasal naloxone

Naloxone Kern Pharma 1 mg in total (from 0.4 mg/mL injectable solution). Study drugs (naloxone nasal spray and naloxone intravenously) will be administered in 8 subjects in two sequences in fasting conditions (10 hours pre-dose and 4 hours post dose): Intranasal -\> washout period -\>intravenous (n=4) and Intravenous -\>washout period -\> intranasal (n=4).

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Parc de Salut Mar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06306391 on ClinicalTrials.gov