Unfractionated heparin is used for the prevention and treatment of deep vein thrombosis and complications hereof
Conditions
Interventions
Trade Name: Heparin "LEO", injektionsvæske, opløsning 5.000 IE/ml
Product Name: Heparin "LEO", injektionsvæske, opløsning 5.000 IE/ml
Pharmaceutical Form: Solution for injection in vial
Sponsors
Bispebjerg-Frederiksberg Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • History or sign of bleeding disorders • History or sign of kidney disease • History or sign of liver disease • Average systolic blood pressure 140 mmHg and/or average diastolic blood pressure 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): Difference between interventions in change in incremental aPTT;Timepoint(s) of evaluation of this end point: Peak aPTT for 1-8 hours after UFH injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference between interventions in change in incremental plasma heparin;Timepoint(s) of evaluation of this end point: Peak plasma heparin for 1-8 hours after UFH injection | — |
Countries
Denmark
Contacts
Public ContactDepartment of Clinical Pharmacology
Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital
Outcome results
None listed