drugset / Trial / NCT06174961

The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin

NCT06174961

Phase 4 Completed 23 enrolled Kristian Karstoft
RandomizedCrossoverOpen-labelTreatment

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 is hypothesized that exercise will increase the systemic exposure (PK) and therefore the clinical effects (PD) of the sc administered UFH. To assess this, healthy male volunteers will be included in a controlled, randomized, crossover study, where they, on four separate days, will have UFH injected sc in the thigh, followed by different exercise interventions (one per experimental day). Blood sampling, with the aim of assessing PK and PD will be performed during the following hours.

Timeline

Start
2023-09-22
Primary completion
2024-02-13
Completion
2024-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Heparin Other / unclassified 15000 iu Subcutaneous