Bioavailability of Dexmedetomidine After Intranasal Administration - Full Text View

Sponsor:	University of Turku
Information provided by:	University of Turku
ClinicalTrials.gov Identifier:	NCT00837187

Purpose

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.

Condition	Intervention	Phase
Sedation	Drug: Intravenous dexmedetomidine Drug: Intranasal dexmedetomidine	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Bioavailability of Dexmedetomidine After Intranasal Administration in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Turku:

Primary Outcome Measures:

The absolute bioavailability of intranasally administered dexmedetomidine [ Time Frame: At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 4, 5, 6, 8 and 10 h. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The effects of intranasally and intravenously administered dexmedetomidine on plasma catecholamine levels, systemic blood pressure, heart rate and sedation, local and systemic safety and tolerability of intranasal dexmedetomidine. [ Time Frame: At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 5 and 10 h. Only local nasal tolerability is assessed at 5 and 10 h. ] [ Designated as safety issue: Yes ]

Enrollment:	7
Study Start Date:	March 2009
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Intravenous dexmedetomidine Dexmedetomidine is administered intravenously	Drug: Intravenous dexmedetomidine 100 ug
Experimental: Intranasal administration Dexmedetomidine is administered intranasally	Drug: Intranasal dexmedetomidine 100 ug

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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)].

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837187

Locations

Finland
Turku University Hospital
Turku, Finland, 20520

Sponsors and Collaborators

University of Turku

Investigators

Principal Investigator:	Timo Iirola, MD	Turku University Hospital
Study Director:	Klaus T Olkkola, MD, PhD, Professor	Turku University Hospital

More Information

No publications provided by University of Turku

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT. Bioavailability of dexmedetomidine after intranasal administration. Eur J Clin Pharmacol. 2011 Aug;67(8):825-31. Epub 2011 Feb 12.

Responsible Party:	Timo Iirola, Turku University Hospital
ClinicalTrials.gov Identifier:	NCT00837187 History of Changes
Other Study ID Numbers:	INDEX
Study First Received:	February 4, 2009
Last Updated:	January 12, 2010
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by University of Turku:

dexmedetomidine
intranasal
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:

Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012