healthy volunteers are studied.
Conditions
Interventions
Trade Name: Dexdor
Pharmaceutical Form: Infusion
INN or Proposed INN: DEXMEDETOMIDINE
CAS Number: 113775-47-6
Sponsors
University Of Turku
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Fluent skills in the Finnish language in order to be able to give informed consent and communicate with the study personnel. 2. Age = 18 years. 3. Male gender. 4. Weight = 60 kg. 5. Written informed consent from the subject. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous history of intolerance to the study drug or related compounds and additives. 2. Concomitant drug therapy of any kind except paracetamol in the 14 days prior to the study. 3. Existing or recent significant disease. 4. History of hematological, endocrine, metabolic or gastrointestinal disease. 5. History of asthma or any kind of drug allergy. 6. 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. 7. Donation of blood within six weeks prior to and during the study. 8. Special diet or lifestyle factors which would compromise the conditions of the study or the interpretation of the results. 9. BMI > 30 kg / m2. 10. Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study. 11. Smoking during one month before the start of the study or during the study period. 12. 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)].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: In addition, we will report the effects of subcutaneously administered dexmedetomidine on plasma catecholamine levels, vital signs such as systemic blood pressure, heart rate and sedation. We will also monitor the local and systemic safety and tolerability of subcutaneously administered dexmedetomidine.;Primary end point(s): Quantitate the bioavailability of subcutaneously given dexmedetomidine in ten volunteers;Timepoint(s) of evaluation of this end point: 24 h after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Characterize the pharmacokinetics and –dynamics of subcutaneously given dexmedetomidine;Timepoint(s) of evaluation of this end point: 24 h after administration | — |
Countries
Finland
Contacts
Public ContactDepartment of Anesthesiology and In
University Of Turku
Outcome results
None listed