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Study of Inhaled Epinephrine and Intramuscular Epinephrine Administered to Healthy Adults

NCT05152901 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-07-24

No results posted yet for this study

Summary

This is a study to determine the relative bioavailability of inhaled epinephrine compared with 0.3mg epinephrine administered IM in healthy male and female participants.

Conditions

  • Anaphylactic Reaction

Interventions

DRUG

EpiPen ®.

A single dose of 0.3 mg epinephrine via intramuscular injection into the anterolateral aspect of the thigh on Day 1 Visit 2.

DRUG

Epinephrine (0.3mg) inhaled

Participants will be administered 0.3mg of first inhaled dose of epinephrine once daily on day 2 of Visit 2

DRUG

Epinephrine (1.3mg)

A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 1.3 mg epinephrine.

DRUG

Epinephrine (4mg)

A single inhaled dose or split into 2 administrations (administered less than 1 minute apart) of a planned dose of 4 mg epinephrine

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • De Motu Cordis

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-01-06
Primary Completion
2022-06-06
Completion
2022-06-06

Countries

  • Australia

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 NCT05152901 on ClinicalTrials.gov