Status:
COMPLETED
The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin
Lead Sponsor:
Kristian Karstoft
Conditions:
Blood Coagulation Disorder
Eligibility:
MALE
18-50 years
Phase:
PHASE4
Brief Summary
The aim of this project is to assess the influence of exercise on pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of subcutaneously (sc) administered unfractionated heparin (UFH). It ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
September 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06174961
Start Date
September 22 2023
End Date
May 1 2024
Last Update
June 26 2024
Active Locations (1)
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1
Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology
Copenhagen, Denmark, 2400