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

Not Applicable

Completed

• Conditions: Anaphylaxis
• Interventions: Drug: Epinephrine

• Registration Number: NCT01432522
• Lead Sponsor: Siriraj Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-01-19
• Primary Completion: 2011-08
• Status Verified: 2011-09
• Study Completion: 2011-09
• Study First Submitted QC: 2011-09-12
• Last Update Submitted: 2011-09-12
• Study First Posted: 2011-09-13
• Last Update Posted: 2011-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
epinephrine IN, epinephrine IM, saline IN	Epinephrine	1. Intranasal saline 2. Intramuscular epinephrine 3. Intranasal epinephrine

Primary Outcome Measures

Name	Time	Method
Composite of Pharmacokinetics of epinephrine	predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose	Cmax, Area Under Curve, Tmax of epinephrine compare between 0.3 mg intramuscular and 5 mg intranasal route

Secondary Outcome Measures

Name	Time	Method
Numbers of participants with adverse events as a measure of safety and tolerability	1 year	Any side effects from such administration such as bad smelling, sorethroat.

Trial Locations

Locations (1)

Facaulty of Medicine, Siriraj Hospital; 🇹🇭 Bangkok, Thailand