- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00837187
Bioavailability of Dexmedetomidine After Intranasal Administration (INDEX)
Bioavailability of Dexmedetomidine After Intranasal Administration in Healthy Subjects
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Turku, Finland, 20520
- Turku University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)].
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intravenous dexmedetomidine
Dexmedetomidine is administered intravenously
|
100 ug
|
Experimental: Intranasal administration
Dexmedetomidine is administered intranasally
|
100 ug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 4, 5, 6, 8 and 10 h.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Timo Iirola, MD, Turku University Hospital
- Study Director: Klaus T Olkkola, MD, PhD, Professor, Turku University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- INDEX
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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