Status:
COMPLETED
Bioavailability of Dexmedetomidine After Intranasal Administration
Lead Sponsor:
University of Turku
Conditions:
Sedation
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 \[routine haematology (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelets), renal function tests (creatinine, urea) and liver function tests (bilirubin)\].
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00837187
Start Date
March 1 2009
End Date
May 1 2009
Last Update
January 13 2010
Active Locations (1)
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1
Turku University Hospital
Turku, Finland, 20520