drugset / Trial / NCT00413088
Study to Assess Bemiparin Pharmacokinetics in Renal Insufficiency and in the Elderly
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2006-03
- Primary completion
- 2011-02
- Completion
- 2011-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bemiparin | Other / unclassified | 115 iu/kg | Subcutaneous |
| Subject | Bemiparin | Other / unclassified | 3500 iu | Subcutaneous |