A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine

Siriraj Hospital12 enrolled

Overview

This study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.

Patients are reluctant to use Epipen® on emergency basis, perhaps because of improperly training, hesitancy and fear of needle. Other route of administration of epinephrine (EPI) may be more benefit such as intranasal route.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anaphylaxis

Interventions

EpinephrineDRUG

1. Intranasal epinephrine 5 mg /spray 2. Intramuscular epinephrine 0.3 mg 3. Intranasal saline spray

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy subjects 2. 18-30 years-old Exclusion Criteria: 1. Pregnancy 2. Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine

Locations (1)

Facaulty of Medicine, Siriraj Hospital

Bangkok, Bangkok, Thailand

Outcomes

Primary Outcomes

Composite of Pharmacokinetics of epinephrine

Cmax, Area Under Curve, Tmax of epinephrine compare between 0.3 mg intramuscular and 5 mg intranasal route

Time frame: predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose

Secondary Outcomes

Numbers of participants with adverse events as a measure of safety and tolerability

Any side effects from such administration such as bad smelling, sorethroat.

Time frame: 1 year

Data from ClinicalTrials.gov

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