Bioavailability of Subcutaneous Dexmedetomidine

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Turku University Hospital
• Treatments: Dexmedetomidine

Criteria

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