Inclusion Criteria:
Non-elderly healthy volunteers (Group I):
- Male or female subjects aged between 18 and 65 years
- body weight, clinical history, physical examination, vital signs (systolic and diastolic blood pressure, heart beat rate and body temperature), ECG and laboratory tests (hemogram and biochemistry) within normal range
- without evidence of significant organic or psychiatric illness
- who have accepted to participate in the study and have signed the written informed consent.
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:
- Group II: mild renal insufficiency (creatinine clearance > 50 to 80 ml/min);
- Group III: Moderate renal insufficiency (creatinine clearance: 30 to 50 ml/min);
- Group IV: Severe renal insufficiency (creatinine clearance < 30 ml/min). The degree of renal insufficiency will be calculated on the basis of determination of creatinine clearance measuring total urinary output over a 24-h period and serum creatinine levels. Urine samples will be collected no more than 2 weeks before the first experimental period.
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):
- Male or female subjects aged > 65 years old who fulfill with the remaining inclusion criteria specified for non-elderly healthy volunteers.
Exclusion Criteria:
Non-elderly healthy volunteers (Group I):
- Previous history of alcoholism or drugs consumption
- Important consumer of exciting drinks
- Hypersensitivity, allergy, idiosyncrasy to medicines
- Taking another medication four weeks before the initiation of the trial including medication without prescription and medicinal plants
- Positive serology of hepatitis B, C or HIV virus
- History or clinic evidence of concomitant disease
- Familiar history of coagulation's disorders
- surgery within the previous 6 months
- Women who are pregnant or who are not using effective contra conceptive methods
- Ethanol, cannabis, cocaine, amphetamine, benzodiazepin or opiate in urine
- Current platelet count < 100.000/mm3 or serum K > 5,5 mEq/L
- Any contraindication to bemiparin administration in order to authorized summary product characteristics
- Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
- To give blood in the four weeks before beginning of the trial
Patients with renal insufficiency or elderly healthy volunteers (Groups II, III, IV, V):
- Previous history of alcoholism or drugs consumption
- Important consumer of exciting drinks
- Hypersensitivity, allergy, idiosyncrasy to medicines
- Treatment with enzymatic inhibitors or inductors medicines
- Administration with ASA of dosis > 125 mg/day and/or NDAIs with half-life > 20 hours or with high antiagregant effect during the previous ten days to the inclusion
- Chronic hepatopatology
- bilirubin levels > 1,5 mg/dl and/or increment of AST/ALT levels twice higher than maximum limit of normality
- prothrombin time 20% higher than maximun limit of normality and haemoglobine < 8gr/dl or albumim levels <3gr/dl
- Previous history of acute infarction of myocardium, cardiac ischemic or arrhythmia
- Acute illness in the previous week to the participation
- Familiar history of coagulation's disorders
- surgery within the previous 6 months
- Women who are pregnant or who are not using effective contra conceptive methods
- Ethanol, cannabis, cocaine, amphetamine, benzodiazepin or opiate in urine
- Current platelet count < 75.000/mm3 or serum K > 6 mEq/L
- Any contraindication to bemiparin administration in order to authorized summary product characteristics
- Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
- To give blood in the four weeks before beginning of the trial
- Subjects in haemodialysis or peritoneal dialysis