Pharmacokinetic Study of Two Oral Bemiparin Formulations

NCT ID: NCT00863577

Last Updated: 2011-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-01-31

Brief Summary

The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa activity

Conditions

Healthy

Study Design

• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

Oral bemiparin

Bemiparin tablets and bemiparin tablets into hard gelatine capsules

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rovi Pharmaceuticals Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Medical Department

Locations

Hospital Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

ROV-BEM-2008-01

Identifier Type: -

Identifier Source: org_study_id