NCT00837187

Bioavailability of Dexmedetomidine After Intranasal Administration

Bioavailability of Dexmedetomidine After Intranasal Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Turku · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In a recent study by Yuen et al it was shown that preoperative intranasal administration of dexmedetomidine is a useful alternative for oral midazolam in children. However, there is no information on the pharmacokinetics of dexmedetomidine after intranasal administration. The aim of this study is to investigate the comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of intranasally administered dexmedetomidine will be calculated. In addition, we will report the effects of intranasally and intravenously administered dexmedetomidine on plasma catecholamine levels, systemic blood pressure, heart rate and sedation. We will also monitor the local and systemic safety and tolerability of intranasally administered dexmedetomidine.

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	Intravenous dexmedetomidine	100 ug
DRUG	Intranasal dexmedetomidine	100 ug

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2009-02-05
• Last updated: 2010-01-13

Locations

1 site across 1 country: Finland