Bioavailability of Subcutaneous Dexmedetomidine (ScDex)

Turku University Hospital (TYKS)

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02724098

T30/2016

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

intravenous

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

subcutaneous

Active Comparator group

Description:

1 µg/kg dexmedetomidine (dexmedetomidine hydrochloride 100 microg/ml, Dexdor® Orion Oyj, Espoo, Finland) will be administered subcutaneously undiluted.

Treatment:

Drug: Dexmedetomidine