Bioavailability of Dexmedetomidine After Intranasal Administration

Sedation Clinical Trial

— INDEX  

Official title:

Bioavailability of Dexmedetomidine After Intranasal Administration in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837187
• Other study ID #: INDEX
• Status: Completed
• Phase: Phase 1
• First received: February 4, 2009
• Last updated: January 12, 2010
• Start date: March 2009
• Est. completion date: May 2009

Study information

• Verified date: January 2009
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• Intravenous dexmedetomidine
100 ug
• Intranasal dexmedetomidine
100 ug

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absolute bioavailability of intranasally administered dexmedetomidine		At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 4, 5, 6, 8 and 10 h.	No
Secondary	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.		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.	Yes