E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Unfractionated heparin is used for the prevention and treatment of deep vein thrombosis and complications hereof | Ufraktioneret heparin bruges til forebyggelse og behandling af dyb venetrombose og komplikationer til dette | |
E.1.1.1 | Medical condition in easily understood language | Unfractionated heparin is used for the prevention and treatment of deep vein thrombosis and complications hereof | Ufraktioneret heparin bruges til forebyggelse og behandling af dyb venetrombose og komplikationer til dette | |
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
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 | To assess the effect of a single exercise session (with both legs) on pharmacodynamics and pharmacokinetics of a single dose of subcutaneously administered unfractionated heparin. | At undersøge om akut fysisk aktivitet kan påvirke effekt og koncentration af en enkelt dosis ufraktioneret heparin | |
E.2.2 | Secondary objectives of the trial | To assess the effect of a single exercise session (with one leg) on pharmacodynamics and pharmacokinetics of a single dose of subcutaneously administered unfractionated heparin, administered in the exercising vs. the non-exercising leg, respectively. | At undersøge om akut fysisk aktivitet (med et ben) påvirkes effekt og koncentration af en enkelt dosis ufraktioneret heparin forskelligt, afhængigt af om heparin administreres i det arbejdende eller det ikke-arbejdende ben | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | •Male between 18 and 50 years old •Body weight 50 kg or more •Body Mass Index 18.5−25 kg/m2 •Acceptance of not drinking alcohol for 24 hours before to 24 hours after dosing of study drug •Acceptance of not performing physical activity for 24 hours before to 24 hours after dosing of study drug •Signed informed consent form | •Mand mellem 18 og 50 år •Vægt over 50 kg •BMI 18,5-25 kg/m2 •Accept af ikke at drikke alkohol fra 24 timer før og til 24 timer efter hver indgift af ufraktioneret heparin •Accept af ikke at være fysisk aktiv fra 24 timer før og til 24 timer efter hver indgift af ufraktioneret heparin •Underskrevet erklæring vedr. informeret samtykke | |
E.4 | Principal exclusion criteria | •History or sign of bleeding disorders •History or sign of kidney disease •History or sign of liver disease •Average systolic blood pressure <100 mmHg or >140 mmHg and/or average diastolic blood pressure <60 mmHg or >90 mmHg (average of three measurements performed at screening). •Daily pharmaceutical treatment •Contraindication to increased levels of physical activity (10) •Smoking or other regular use of any form of nicotine products during the study period and the previous 3 months. •Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator). •Previous treatment with heparins •Low levels of anti-thrombin (P-antitrombin(enz.) <0,80 kIU/L) | •Tegn til eller kendt forstyrrelse i blødnings- og koagulationssystemet •Tegn til eller kendt nyresygdom •Tegn til eller kendt leversygdom •Systolisk blodtryk <100 mmHg eller > 150 mmHg •Diastolisk blodtryk <60 mmHg eller > 90 mmHg •Daglig medicinsk behandling •Rygning indenfor de seneste 3 måneder •Tilstande der medfører at fysisk aktivitet ikke må udføres •Aktuel eller nylig (indenfor 3 måneder) deltagelse i andre kliniske forsøg •Tidligere behandling med heparin •Lavt niveau af anti-thrombin (et enzym der er nødvendigt for at heparin virker og som måles via en blodprøve) | |
E.5 End points |
E.5.1 | Primary end point(s) | Difference between interventions in change in incremental aPTT | Forskelle mellem interventioner i ændring i aPTT | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | Peak aPTT for 1-8 hours after UFH injection | Maks aPTT i 1-8 timer efter UFH injektion | |
E.5.2 | Secondary end point(s) | Difference between interventions in change in incremental plasma heparin | Forskelle mellem interventioner i ændring i plasma heparin | |
E.5.2.1 | Timepoint(s) of evaluation of this end point | Peak plasma heparin for 1-8 hours after UFH injection | Maks plasma heparin i 1-8 timer efter UFH injektion | |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description | Injection of IMP subcutaneously in different legs | |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |