Healthy
Conditions
Keywords
Healthy volunteers
Brief summary
The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa activity
Interventions
DRUGOral bemiparin
Bemiparin tablets and bemiparin tablets into hard gelatine capsules
Sponsors
Rovi Pharmaceuticals Laboratories
Study design
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy volunteers: male or female subjects aged between 18 and 45 years 2. Body weight: 65-80 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 11. contraceptive methods double barrel or sterile surgery
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, benzodiazepin or opiate in urine 10. Healthy volunteers with a familiar history evident hemorrhagic episodes 11. positive fecatest and comburtest 12. positive pregnant test 13. Bemiparin contraindication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa activity | pre-medication, +1 h , +2 h, +3h, +4 h , +5h, +6 h, +8 h, +10h, +12h, +18 h, +24 h,+25h, +26h, +27h, +28h, +29h, +30h, +32h, +34h, +36h, +42h, +48 h, +60 h and +72 h |
Countries
Spain
Outcome results
None listed