Pharmacokinetics of Different Mode Administration of Intranasal Dexmedetomidine

The University of Hong Kong (HKU)

Status and phase: Completed; Phase 3

Conditions: Dexmedetomidine; Bioavailability

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03323593

PK InDexm

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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8 participants in 3 patient groups

iv

Active Comparator group

Treatment:

Drug: Dexmedetomidine

drip

Active Comparator group

Treatment:

Drug: Dexmedetomidine

atomizer

Active Comparator group

Treatment:

Drug: Dexmedetomidine