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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bemiparin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacokinetics of bemiparin administered subcutaneously once daily for 4 days at prophylactic doses (3500 IU) and at a single therapeutic dose (115 IU/kg), in renal insufficiency and in the elderly. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of bemiparin in all volunteers and patients. |
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Inclusion Criteria:
Non-elderly healthy volunteers (Group I):
Patients with renal insufficiency (Groups II, III and IV):
Male or female subjects aged between 18 and 65 years, who will be assigned to one of the following groups according to renal function:
Patients with renal insufficiency must have a stable renal function during the 3 months before their inclusion in the study.
They must have a body weight between 45 and 110 Kg.
They have to accept to participate in the study and have signed the written informed consent.
Elderly healthy volunteers (Group V):
Exclusion Criteria:
Non-elderly healthy volunteers (Group I):
Patients with renal insufficiency or elderly healthy volunteers (Groups II, III, IV, V):
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| Name | Affiliation | Role |
|---|---|---|
| Manuel Barbanoj, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau and Fundació Puigvert | Barcelona | Barcelona | 08008 | Spain |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C411345 | bemiparin |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |