Skip to main content
OpenTrials
Completed

NCT Number: NCT03323593

Pharmacokinetics of Different Mode Administration of Intranasal Dexmedetomidine

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bioavailability Dexmedetomidine

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Queen Mary Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

healthy volunteer ASA 1 age over 18 no other concomitant drug therapy no alcohol or smoking habit -

Exclusion criteria

-

Treatment and study plan

Dexmedetomidine

Drug

blood is sampled for quantification of plasma concentration after intravenous, intranasal by atomisation and intranasal by drops.

Primary outcomes

  1. Bioavailability of dexmedetomidine

    Time frame: 8 hours

Secondary outcomes

  1. sedation score

    Time frame: 8 hours

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 27, 2017
Registry last updated
Oct 27, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.