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Bioavailability of Nasal Epinephrine

NCT04696822 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-01-05

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 with Epinephrine 0.3 mg Intramuscular Injection in Adult Subjects with Seasonal Allergic Rhinitis with and without Nasal Allergen Challenge

Conditions

Interventions

DRUG

Epinephrine Nasal Product, 1.6 mg

Single dose Nasal powder spray without allergen challenge

DRUG

Epinephrine nasal product, 1.6 mg + allergen

Single dose Nasal powder spray with allergen challenge

DRUG

Epinephrine Injection 0.3 mg

Intramuscular injection

DRUG

Epinephrine Nasal Product, 3.2 mg

Twice dose Nasal powder spray without allergen challenge

DRUG

Epinephrine Nasal Product, 3.2 mg + allergen

Twice dose Nasal powder spray with allergen challenge

Sponsors & Collaborators

  • Nasus Pharma

    lead INDUSTRY

Principal Investigators

  • Yoseph Caraco, Prof. · Hadassah Medical Organization

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2021-09-28
Completion
2021-09-28

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 NCT04696822 on ClinicalTrials.gov