A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection|
- Composite of Pharmacokinetics of epinephrine [ Time Frame: predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose ] [ Designated as safety issue: Yes ]Cmax, Area Under Curve, Tmax of epinephrine compare between 0.3 mg intramuscular and 5 mg intranasal route
- Numbers of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Any side effects from such administration such as bad smelling, sorethroat.
|Study Start Date:||July 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: epinephrine IN, epinephrine IM, saline IN
Other Name: adrenaline
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.
|Facaulty of Medicine, Siriraj Hospital|
|Bangkok, Thailand, 10700|
|Study Director:||Pakit Vichyanond, MD.||Siriraj medical school, Mahidol Univrsity|