Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of a New Ultra Low Molecular Weight Heparin (RO-14) Administered Subcutaneously Increasing Single-doses to Healthy Male Volunteers

Inclusion criteria

• Healthy volunteers: male subjects aged between 18 and 45 years
• Body weight: 65-75 Kg
• Not meaningful abnormalities in physical examination and in clinical history
• Without evidence of significant organic or psychiatric illness
• Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory
• Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range
• Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
• Not give blood in the last 4 weeks.
• Healthy male volunteers who have not received heparin in the past
• Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent

Exclusion criteria

• Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption
• Important consumption of exciting drinks: alcohol consumption > 30 g/day; coffee, tea, cola > 5 /day
• Allergy, idiosyncrasy or hypersensitivity to medicines
• Healthy volunteers who are receiving another medication in the past 15 days
• Positive serology of hepatitis B, C or HIV
• Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events
• Mayor Surgery in the last 6 months
• Smoking > 10 cigarettes / day
• Ethanol, cannabis, cocaine, amphetamine, benzodiazepine or opiate in urine
• Healthy volunteers with a familiar history evident hemorrhagic episodes