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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

Page last updated: August 20, 2015

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