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Pharmacokinetic Study of Two Oral Bemiparin Formulations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863577
Recruitment Status : Completed
First Posted : March 18, 2009
Last Update Posted : March 18, 2011
Sponsor:
Information provided by:
Rovi Pharmaceuticals Laboratories

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Oral bemiparin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : March 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Intervention Details:
  • Drug: Oral bemiparin
    Bemiparin tablets and bemiparin tablets into hard gelatine capsules


Primary Outcome Measures :
  1. The primary pharmacokinetic analysis will be the correlation of the AUC amidolytic anti-Xa activity [ Time Frame: 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863577


Locations
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Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08025
Sponsors and Collaborators
Rovi Pharmaceuticals Laboratories
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Responsible Party: Medical Department
ClinicalTrials.gov Identifier: NCT00863577    
Other Study ID Numbers: ROV-BEM-2008-01
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: March 18, 2011
Last Verified: March 2011
Keywords provided by Rovi Pharmaceuticals Laboratories:
Healthy volunteers
Additional relevant MeSH terms:
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Bemiparin
Anticoagulants