Comparative Bioavailability of Intranasal Epinephrine

Status Completed

Clinical Trial 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

Clinical Trial Description

An open-label trial in 12 healthy adults. FMXIN002 (3.6 mg and 4.0 mg) will be administered intranasally to healthy adults and compared to IM (0.3mg, EpiPen) by Epinephrine pharmacokinetics, pharmacodynamic response and clinical safety. (https://my.health.gov.il/CliniTrials/Pages/MOH_2023-07-01_012776.aspx.) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06205134
Study type	Interventional
Source	Nasus Pharma
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	August 22, 2023
Completion date	February 5, 2024

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT04475003` - Health Literacy Among Caregivers of Children With IgE-mediated Allergy With Risk of Anaphylaxis
Recruiting	`NCT04615065` - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Recruiting	`NCT06065137` - Standardised Drug Provocation Testing in Perioperative Hypersensitivity	N/A
Completed	`NCT00047918` - Blood Factors in Mastocytosis and Unexplained Anaphylaxis and Flushing	N/A
Active, not recruiting	`NCT03953482` - Evaluation of Medical Care and Patient's Knowledge About the Behavior to Take on Secondary Prevention of Anaphylaxis
Recruiting	`NCT05112367` - Epidemiology and Management of Pediatric Anaphylaxis and Allergy in the Pediatric Emergency Department of Montpellier
Completed	`NCT03366298` - Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers	Phase 4
Completed	`NCT02958605` - Smartphone Apps for Pediatric Resuscitation	N/A
Completed	`NCT04696822` - Bioavailability of Nasal Epinephrine	Phase 1
Completed	`NCT03942692` - What is the Allergy Follow-up for Children After Anaphylactic Reaction? AFCAR : Allergy Follow-up for Children After Anaphylactic Reaction
Completed	`NCT02854969` - Satisfaction of Patient With Anaphylaxis in the Use of a Medical Device	N/A
Completed	`NCT03282929` - Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)	Phase 1
Recruiting	`NCT01326741` - Clonal Mast Cell Disorders in Exercise-Induced Anaphylaxis	N/A
Recruiting	`NCT06445374` - Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges	Phase 1
Completed	`NCT01217138` - Make up for the Epinephrine Autoinjector	Phase 4
Completed	`NCT02424136` - PEAnut Anaphylaxis Predictors	N/A
Completed	`NCT01432522` - A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine	N/A
Completed	`NCT02028065` - A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy Participants (MK-8616-101)	Phase 1
Active, not recruiting	`NCT01247415` - Clinical Investigation on Allergic-like Reactions and Oculo-respiratory Syndrome After the H1N1 Pandemic Vaccine	N/A
Completed	`NCT00868842` - Desensitization of Human Mast Cells: Mechanisms and Potential Utility for Preventing Anaphylaxis	N/A