NCT01660295

Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects

An Open-label, Single Center, Parallel-group Study to Compare the Single- and Repeated-dose Pharmacokinetics of Stepwise Increasing Doses of Subcutaneous Certoparin (3000 IU o.d., 3000 IU b.i.d., 8000 IU o.d., and 8000 IU b.i.d.) in Subjects With Severe Renal Insufficiency and Healthy Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Certoparin 3,000 IU Once Daily	Certoparin 3,000 IU subcutaneous injection once daily
DRUG	Certoparin 3,000 IU Twice a Day	Certoparin 3,000 IU subcutaneous injection twice a day
DRUG	Certoparin 8,000 IU Once Daily	Certoparin 8,000 IU subcutaneous injection once daily
DRUG	Certoparin 8,000 IU Twice a Day	Certoparin 8,000 IU subcutaneous injection twice a day

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-06-01
• First posted: 2012-08-08
• Last updated: 2012-08-08

Locations

1 site across 1 country: Hungary