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Pharmacokinetics of Different Mode Administration of Intranasal Dexmedetomidine

NCT ID: NCT03323593

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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

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Bioavailability Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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iv

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

drip

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

atomizer

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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YUEN, Vivian Man-ying

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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PK InDexm

Identifier Type: -

Identifier Source: org_study_id