drugset / Trial / NCT00837187

Bioavailability of Dexmedetomidine After Intranasal Administration

NCT00837187

Phase 1 Completed 7 enrolled University of Turku
RandomizedCrossoverOpen-labelBasic science

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.

Timeline

Start
2009-03
Primary completion
2009-05
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 100 ug Intravenous
Subject Dexmedetomidine Other / unclassified 100 ug Intranasal

Indications

No indication recorded.