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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432522
|Facaulty of Medicine, Siriraj Hospital|
|Bangkok, Thailand, 10700|
|Study Director:||Pakit Vichyanond, MD.||Siriraj medical school, Mahidol Univrsity|