Clinical Trials/NCT01432522

NCT01432522CompletedNot Applicable

Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection

Siriraj Hospital1 site in 1 country12 target enrollmentStarted: July 2010Last updated: September 13, 2011

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: Siriraj Hospital
Enrollment: 12
Locations: 1
Primary Endpoint: Composite of Pharmacokinetics of epinephrine

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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 Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to 30 Years (Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Healthy subjects
•18-30 years-old

Exclusion Criteria

•Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine

Arms & Interventions

epinephrine IN, epinephrine IM, saline IN

Experimental

Intranasal saline
Intramuscular epinephrine
Intranasal epinephrine

Intervention: Epinephrine (Drug)

Outcomes

Primary Outcomes

Composite of Pharmacokinetics of epinephrine

Time Frame: 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 Outcomes

Numbers of participants with adverse events as a measure of safety and tolerability(1 year)

Investigators

Sponsor

Siriraj Hospital

Sponsor Class

Other

Responsible Party

Principal Investigator

Pakit Vichyanond, MD

Professor of Pediatrics

Siriraj Hospital

Study Sites (1)

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