A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine
Information source: Siriraj Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anaphylaxis
Intervention: Epinephrine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Siriraj Hospital Official(s) and/or principal investigator(s): Pakit Vichyanond, MD., Study Director, Affiliation: Siriraj medical school, Mahidol Univrsity
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.
Clinical Details
Official title: Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Composite of Pharmacokinetics of epinephrine
Secondary outcome: Numbers of participants with adverse events as a measure of safety and tolerability
Detailed description:
Patients are reluctant to use EpipenŽ 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 30 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Facaulty of Medicine, Siriraj Hospital, Bangkok 10700, Thailand
Additional Information
Starting date: July 2010
Last updated: September 12, 2011
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