Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects
Renal Insufficiency
About this trial
This is an interventional treatment trial for Renal Insufficiency focused on measuring Severe renal insufficiency certoparin, Severe renal insufficiency
Eligibility Criteria
Inclusion criteria:
- Healthy subjects OR
- Subjects with severe renal insufficiency
Exclusion criteria:
- Hypersensitivity to study medication
- Genetic abnormality or disease of clotting system
- Prior major surgery or bleeding
- Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- DRC Drug Research Center Ltd., H-8230 Balatonfüred
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Certoparin control
Certoparin Renal
Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria.
Participants receive dose escalation upon medical criteria qualification at each period: Certoparin 3,000 IU once a day during period 1. Certoparin 3,000 IU twice a day during period 2. Certoparin 8,000 IU once a day during period 3. Certoparin 8,000 IU in the morning and 3,000 IU in the evening during period 4 OR Certoparin 8,000 IU twice a day during period 4.