E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
healthy volunteers are studied. |
tutkittavat ovat terveitä |
|
E.1.1.1 | Medical condition in easily understood language |
healthy volunteers are studied. |
tutkittavat ovat terveitä |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Tässä tutkimuksessa selvitetään ihon alle annostellun deksmedetomidiinin imeytymistä ja muuta farmakokinetiikkaa. |
|
E.2.2 | Secondary objectives of the trial |
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. |
Toisena päämääränä on selvittää ihon alle annostellun deksmedetomidiinin vaikutuksia katekoliamiinien pitoisuuksiin, vitaaliparametreihin (kuten verenpaine ja syketiheys) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
1. Sujuva suomenkielen taito
2. Ikä ≥ 18 vuotta.
3. Miessukupuoli.
4. Paino ≥ 60 kg
5. Kirjallinen suostumus (informed consent) saatu |
|
E.4 | Principal 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)]. |
1. Tutkimuksessa käytettävän lääkkeen tai sen apuaineiden sopimattomuus
2. Muu mikä tahansa lääkehoito 14 päivää ennen tutkimusta. Parasetamolin käyttö sallittua.
3. Nykyinen tai aiempi merkittävä perussairaus
4. Nykyinen tai aiemmin sairastettu hematologinen, sisäerityksellinen, aineenvaihdunnallinen tai maha-suolikanavan tauti.
5. Mikä tahansa lääkeyliherkkyys.
6. Alkoholiriippuvuus, alkoholin käyttö tutkimuksen aikana, huumausaineiden käyttö tai psyykkiset ongelmat jotka voivat vaikeuttaa tutkimuksen kulkua tai tutkittavan saamaa informaation ymmärtämistä.
7. Verenluovutus 6 viikkoa ennen tutkimusta tai tutkimuksen aikana
8. Erityinen dieetti tai elämäntapa, joka voisi vaarantaa tutkimuksen tulosten tulkinnan.
9. Paino alle 60 kg tai BMI yli 30 kg / m2.
10. Osallistuminen muuhun lääketutkimukseen alle kuukautta edeltävällä ajalla tästä tutkimuksesta.
11. Tupakointi alle kuukausi ennen tutkimusta tai tutkimuksen aikana.
12. Kliinisesti merkittävät poikkeavuudet lääkärin tutkimuksessa, EKG:ssa tai laboratorioarvoissa |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Quantitate the bioavailability of subcutaneously given dexmedetomidine in ten volunteers |
Deksmedetomidiinin absoluuttinen hyötyosuus ihonalaisannostelun jälkeen |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 h after administration |
24 tuntia annostelun jälkeen |
|
E.5.2 | Secondary end point(s) |
Characterize the pharmacokinetics and –dynamics of subcutaneously given dexmedetomidine |
Ihon alle annostellun deksmedetomidiinin farmakokinetiikka ja -dynamiikka. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
24 h after administration |
24 tuntia annostelun jälkeen |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Viimeinen tutkimuskäynti suoritettu. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |