Bioavailability of Dexmedetomidine After Intranasal Administration

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

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-05-31

Brief Summary

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In a recent study by Yuen et al it was shown that preoperative intranasal administration of dexmedetomidine is a useful alternative for oral midazolam in children. However, there is no information on the pharmacokinetics of dexmedetomidine after intranasal administration.

The aim of this study is to investigate the comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of intranasally administered dexmedetomidine will be calculated. In addition, we will report the effects of intranasally and intravenously administered dexmedetomidine on plasma catecholamine levels, systemic blood pressure, heart rate and sedation. We will also monitor the local and systemic safety and tolerability of intranasally administered dexmedetomidine.

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Detailed Description

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Conditions

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Sedation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intravenous dexmedetomidine

Dexmedetomidine is administered intravenously

Group Type ACTIVE_COMPARATOR

Intravenous dexmedetomidine

Intervention Type DRUG

100 ug

Intranasal administration

Dexmedetomidine is administered intranasally

Group Type EXPERIMENTAL

Intranasal dexmedetomidine

Intervention Type DRUG

100 ug

Interventions

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Intravenous dexmedetomidine

100 ug

Intervention Type DRUG

Intranasal dexmedetomidine

100 ug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Fluent skills in the Finnish language in order to be able to give informed consent and communicate with the study personnel.
* Age ≥ 18 years.
* Male gender.
* Weight ≥ 60 kg.
* Written informed consent from the subject.

Exclusion Criteria

* Previous history of intolerance to the study drug or related compounds and additives.
* Concomitant drug therapy of any kind except paracetamol in the 14 days prior to the study.
* Existing or recent significant disease.
* History of hematological, endocrine, metabolic or gastrointestinal disease.
* History of asthma or any kind of drug allergy.
* Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
* Donation of blood within six weeks prior to and during the study.
* Special diet or lifestyle factors which would compromise the conditions of the study or the interpretation of the results.
* BMI \> 30 kg / m2.
* Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
* Smoking during one month before the start of the study or during the study period.
* Clinically significant abnormal findings in physical examination, ECG or laboratory screening \[routine haematology (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelets), renal function tests (creatinine, urea) and liver function tests (bilirubin)\].

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes