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Completed

NCT Number: NCT01432522

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.

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Key information

Conditions

Anaphylaxis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facaulty of Medicine, Siriraj Hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects
  • 18-30 years-old

Exclusion criteria

  • Pregnancy
  • Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine

Treatment and study plan

Epinephrine

Drug
  • Intranasal epinephrine 5 mg /spray
  • Intramuscular epinephrine 0.3 mg
  • Intranasal saline spray

Other names: adrenaline

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Collaborators

  • Mahidol University

Registry information

Official study title

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

Acronym: Epinephrine

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 13, 2011
Registry last updated
Sep 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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