Clinical Trial: A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Siriraj Hospital

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Numbers of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]

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


Original Secondary Outcome: Same as current

Information By: Siriraj Hospital

Dates:
Date Received: January 19, 2011
Date Started: July 2010
Date Completion:
Last Updated: September 12, 2011
Last Verified: September 2011