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Comparative Bioavailability of Intranasal Epinephrine

NCT06205134 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-06-18

No results posted yet for this study

Summary

A Study to Compare the Bioavailability of Epinephrine following a Single Nasal Dose of FMXIN002 Microspheres Powder 3.6 mg, and 4mg with EpiPen 0.3mg Intramuscular Injection in Healthy Adults

Conditions

Interventions

DRUG

A: Epinephrine injection

Autoinjector for intramuscular, single-use, 0.3mg

DRUG

B: FMXIN002 3.6mg

Nasus Pharma nasal powder spray 3.6 mg, single use in one nostril

DRUG

C: FMXIN002 4.0mg

Nasus Pharma nasal powder spray 4.0 mg, single use in one nostril

Sponsors & Collaborators

  • Hadassah Medical Organization

    collaborator OTHER

  • Medistat Ltd., Israel

    collaborator INDUSTRY

  • Pharma Medica Research, Inc.

    collaborator INDUSTRY

  • Nasus Pharma

    lead INDUSTRY

Principal Investigators

  • Yoseph Caraco, Professor · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-08-22
Primary Completion
2024-02-02
Completion
2024-02-05

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

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 NCT06205134 on ClinicalTrials.gov