Pharmacokinetics of Different Mode Administration of Intranasal Dexmedetomidine
Crossover Pharmacokinetic Study of Two Mode of Administration of Intranasal Dexmedetomidine in Healthy Adult Volunteers
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 24, 2017
CompletedFirst Posted
Study publicly available on registry
October 27, 2017
CompletedOctober 27, 2017
October 1, 2017
7 months
October 24, 2017
October 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Bioavailability of dexmedetomidine
8 hours
Secondary Outcomes (1)
sedation score
8 hours
Study Arms (3)
iv
ACTIVE COMPARATORdrip
ACTIVE COMPARATORatomizer
ACTIVE COMPARATORInterventions
blood is sampled for quantification of plasma concentration after intravenous, intranasal by atomisation and intranasal by drops.
Eligibility Criteria
You may qualify if:
- healthy volunteer ASA 1 age over 18 no other concomitant drug therapy no alcohol or smoking habit -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Mary Hospital
Hong Kong, Hong Kong
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
October 24, 2017
First Posted
October 27, 2017
Study Start
May 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
October 27, 2017
Record last verified: 2017-10