NCT00413088

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

Clinical Trial to Assess Bemiparin Pharmacokinetics at Therapeutic (115 IU/kg) and Prophylactic Doses (3500 IU) Administered Subcutaneously in Single or Multiple Doses in Renal Insufficiency and in the Elderly

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Rovi Pharmaceuticals Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	bemiparin

Timeline

• Start date: 2006-03-01
• Primary completion: 2011-02-01
• Completion: 2011-03-01
• First posted: 2006-12-19
• Last updated: 2011-03-18

Locations

1 site across 1 country: Spain