Pharmacological characteristics of subcutaneously given dexmedetomidine in healthy volunteers

Phase 1

• Conditions: healthy volunteers are studied.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-004698-34-FI
• Lead Sponsor: niversity Of Turku

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-13
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 10

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

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)].

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified