NCT03323593

Pharmacokinetics of Different Mode Administration of Intranasal Dexmedetomidine

Crossover Pharmacokinetic Study of Two Mode of Administration of Intranasal Dexmedetomidine in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Intranasal dexmedetomidine has been studied and used in children for premedication before anaesthesia or fro sedation. It can be administered by simple dripping or by Mucosal Atomization Device (MAD®). Since MAD® delivers intranasal medication in a fine mist, it is possible that absorption and bioavailability would be better compares to simple dripping method. To date no pharmacokinetic information of intranasal dexmedetomidine delivered by either method is available. This investigation is designed to compare the bioavailablity of intranasal dexmedetomidine deliver via simple dipping with tuberculine syringe and MAD® in healthy adults.

Detailed description

This is a three-period crossover double-blinded study. 8 subjects will be recruited and they will attend 3 study sessions after informed written and verbal consent. They would have dexmedetomidine administered via different rout each time, intravenous, intranasal via dripping or intranasal via atomizer. Blood samples are collect to determine bioavailability of each mode of drug delivery.

Conditions

• Bioavailability
• Dexmedetomidine

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	blood is sampled for quantification of plasma concentration after intravenous, intranasal by atomisation and intranasal by drops.

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2017-10-27
• Last updated: 2017-10-27

Locations

1 site across 1 country: Hong Kong