Overview

Study to Assess Bemiparin Pharmacokinetics in Renal Insufficiency and in the Elderly

Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
Open pharmacokinetic study with 5 parallel groups and two treatment phases (bemiparin 3,500 IU multiple dose and bemiparin 115 IU/kg single dose). The bemiparin pharmacokinetic profile will be assessed by measuring its effects on the coagulation cascade. Plasma anti-Xa activity (measured using chromogenic amidolytic assay) in IU per milliliter will be the primary endpoint to assess the pharmacokinetic profile of bemiparin.
Phase:
Phase 1
Details
Lead Sponsor:
Rovi Pharmaceuticals Laboratories
Treatments:
Bemiparin
Heparin, Low-Molecular-Weight