The effect of exercise on pharmacodynamics and pharmacokinetics of a single dose of unfractionated heparin: A randomized, controlled, cross-over study

Bispebjerg-Frederiksberg Hospital0 个研究点目标入组 15 人开始时间: 2023年2月1日最近更新: 2024年3月12日

适应症

试验速览

暂无简介。

•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

•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)

发起方

Bispebjerg-Frederiksberg Hospital