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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous | 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. |
|
| subcutaneous | Active Comparator | 1 µg/kg dexmedetomidine (dexmedetomidine hydrochloride 100 microg/ml, Dexdor® Orion Oyj, Espoo, Finland) will be administered subcutaneously undiluted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability (%) of subcutaneously given dexmedetomidine | Noncompartmental analysis after non-linear mixed effects modelling. | 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemodynamic parameter (blood pressure) | More than 30% change from the baseline in the blood pressure (measured in mmHg) | 10 hours |
| Number of participants with adverse events as a measure of safety and tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Teijo I Saari, MD, PhD | Dept. Anaesthesiology and Intensive Care, University Of Turku | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital | Turku | 20521 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32462542 | Derived | Ashraf MW, Uusalo P, Scheinin M, Saari TI. Population Modelling of Dexmedetomidine Pharmacokinetics and Haemodynamic Effects After Intravenous and Subcutaneous Administration. Clin Pharmacokinet. 2020 Nov;59(11):1467-1482. doi: 10.1007/s40262-020-00900-3. | |
| 29666901 | Derived | Uusalo P, Al-Ramahi D, Tilli I, Aantaa RA, Scheinin M, Saari TI. Subcutaneously administered dexmedetomidine is efficiently absorbed and is associated with attenuated cardiovascular effects in healthy volunteers. Eur J Clin Pharmacol. 2018 Aug;74(8):1047-1054. doi: 10.1007/s00228-018-2461-1. Epub 2018 Apr 17. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 15, 2020 | |
| Reset | Jul 1, 2020 | |
| Release | May 16, 2023 | |
| Reset | Jan 26, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2020 | Jul 1, 2020 | |||
| May 16, 2023 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 7 days |
| Change in hemodynamic parameter (heart rate) | More than 30% change from the baseline in the blood pressure (measured in beats/minute) | 10 hours |
| Jan 26, 2024 |