MedTrace Logo

A Study of Olanzapine After Intranasal and Intramuscular Administration

NCT06600477 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-09-19

No results posted yet for this study

Summary

NRL-4, a nasal spray formulation of the atypical antipsychotic olanzapine is being developed by Neurelis Inc. for use as a rescue medication for acute episodes of agitation in schizophrenia, schizoaffective and bipolar I disorder. Also being tested are different concentrations of Intravail A3. Intravail A3 belongs to a class of nonionic surfactants known as alkylglycosides. Alkylglycosides have been extensively studied for their ability to promote increased bioavailability of drugs via the nasal, oral, and ocular routes.

In this study it will be tested if the olanzapine in the two Test products will show comparable pharmacokinetics, safety and tolerability in comparison to the Reference product through the primary pharmacokinetic parameters Cmax, AUC from time 0 to time t and AUC from time 0 to infinity, and safety assessments, including nasal irritation, sedation and pain scales.

Conditions

  • Healthy

Interventions

DRUG

olanzapine

7.5 mg

Sponsors & Collaborators

  • Neurelis, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2023-11-01
Completion
2023-11-01

Countries

  • Jordan

Study Locations

More Related Trials

Entities

Drugs

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 NCT06600477 on ClinicalTrials.gov