Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects
- Conditions
- Renal Insufficiency
- Interventions
- Registration Number
- NCT01660295
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Certoparin control Certoparin 3,000 IU Once Daily Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria. Certoparin Renal Certoparin 3,000 IU Once Daily 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. Certoparin control Certoparin 8,000 IU Twice a Day Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria. Certoparin Renal Certoparin 3,000 IU Twice a Day 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. Certoparin Renal Certoparin 8,000 IU Twice a Day 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. Certoparin Renal Certoparin 8,000 IU Once Daily 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.
- Primary Outcome Measures
Name Time Method Plasma aXa-Profile: C0 5 days Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by pre-dose trough (C0,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.
Dose regimen, systemic total exposure to aXa (AUC0-τ,ss) 5 days Dosage regimen (3,000 o.d., 3,000 b.i.d., 8,000 o.d., 8,000 IU aXa in the morning plus 3,000 IU aXa in the evening, or 8,000 b.i.d. IU aXa) that yields a systemic total exposure to aXa (AUC0-τ,ss) in REN-patients similar to that achieved with 8,000 b.i.d. IU aXa in CON-subjects.
Plasma aXa-Profile: Cmax 5 days Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by maximum (Cmax,ss), aXa comparing REN-patients with matched CON-subjects studied in parallel.
Plasma aXa-Profile: AUC 5 days Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by total (AUC0-τ,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
DRC Drug Research Center Ltd., H-8230 Balatonfüred
🇭🇺H-8230 Balatonfüred, Ady E. u., Hungary