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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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