Healthy
Conditions
Keywords
pharmacokinetics, ultra low molecular weight heparin
Brief summary
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
Interventions
DRUGRO-14
Sponsors
Rovi Pharmaceuticals Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy volunteers: male subjects aged between 18 and 45 years 2. Body weight: 65-75 Kg 3. Not meaningful abnormalities in physical examination and in clinical history 4. Without evidence of significant organic or psychiatric illness 5. Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory 6. Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range 7. Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months 8. Not give blood in the last 4 weeks. 9. Healthy male volunteers who have not received heparin in the past 10. Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent
Exclusion criteria
1. Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption 2. Important consumption of exciting drinks: alcohol consumption \> 30 g/day; coffee, tea, cola \> 5 /day 3. Allergy, idiosyncrasy or hypersensitivity to medicines 4. Healthy volunteers who are receiving another medication in the past 15 days 5. Positive serology of hepatitis B, C or HIV 6. Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events 7. Mayor Surgery in the last 6 months 8. Smoking \> 10 cigarettes / day 9. Ethanol, cannabis, cocaine, amphetamine, benzodiazepine or opiate in urine 10. Healthy volunteers with a familiar history evident hemorrhagic episodes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers | safety parameters |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives : To evaluate pharmacokinetics profiles of each of single-doses. | anti-Xa activity |
Countries
Spain
Outcome results
None listed