This trial is active, not recruiting.

Condition pain
Treatment dexmedetomidine
Phase phase 4
Sponsor Turku University Hospital
Start date April 2016
End date April 2016
Trial size 10 participants
Trial identifier NCT02724098, T30/2016


The aim of this study is to investigate the pharmacokinetics of subcutaneously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of subcutaneously administered dexmedetomidine will be calculated. In addition, the investigators will report the effects of subcutaneously administered dexmedetomidine on plasma catecholamine levels, vital signs such as systemic blood pressure, heart rate and sedation. The investigators will also monitor the local and systemic safety and tolerability of subcutaneously administered dexmedetomidine.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
(Active Comparator)
1 µg/kg dexmedetomidine (dexmedetomidine hydrochloride 100 microg/ml, Dexdor® Orion Oyj, Espoo, Finland) diluted in 10 ml of sodium chloride will be administered intravenously in 10 min at a constant rate using an infusion pump.
(Active Comparator)
1 µg/kg dexmedetomidine (dexmedetomidine hydrochloride 100 microg/ml, Dexdor® Orion Oyj, Espoo, Finland) will be administered subcutaneously undiluted.

Primary Outcomes

Bioavailability (%) of subcutaneously given dexmedetomidine
time frame: 10 hours

Secondary Outcomes

Change in hemodynamic parameter (blood pressure)
time frame: 10 hours
Number of participants with adverse events as a measure of safety and tolerability
time frame: 7 days
Change in hemodynamic parameter (heart rate)
time frame: 10 hours

Eligibility Criteria

Male participants at least 18 years old.

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 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. - Body weight < 60 kg or 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

Additional Information

Official title Bioavailability of Subcutaneously Given Dexmedetomidine in Healthy Volunteers
Principal investigator Teijo I Saari, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Turku University Hospital.