Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Renal Insufficiency

Treatments: Drug: Certoparin 3,000 IU Once Daily; Drug: Certoparin 8,000 IU Twice a Day; Drug: Certoparin 8,000 IU Once Daily; Drug: Certoparin 3,000 IU Twice a Day

Study type: Interventional

Funder types: Industry

Identifiers

NCT01660295

CMEX839BDE07

2011-001930-40 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Certoparin control

Experimental group

Description:

Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria.

Treatment:

Drug: Certoparin 8,000 IU Twice a Day

Drug: Certoparin 3,000 IU Once Daily

Certoparin Renal

Experimental group

Description:

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.

Treatment:

Drug: Certoparin 3,000 IU Twice a Day

Drug: Certoparin 8,000 IU Once Daily

Drug: Certoparin 8,000 IU Twice a Day

Drug: Certoparin 3,000 IU Once Daily