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Bioavailability of Dexmedetomidine After Intranasal Administration (INDEX)

This study has been completed.
Sponsor:
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT00837187
First received: February 4, 2009
Last updated: January 12, 2010
Last verified: January 2009
History of Changes
  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 1

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:

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):

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 May 16, 2013