Pharmacokinetics of Different Mode Administration of Intranasal Dexmedetomidine

Phase 3

Completed

• Conditions: Dexmedetomidine; Bioavailability
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT03323593
• Lead Sponsor: The University of Hong Kong

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2017-10
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-24
• Last Update Submitted: 2017-10-24
• Study First Posted: 2017-10-27
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

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

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
iv	Dexmedetomidine	-
drip	Dexmedetomidine	-
atomizer	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Bioavailability of dexmedetomidine	8 hours

Secondary Outcome Measures

Name	Time	Method
sedation score	8 hours

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong