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Pharmacokinetic Study of Two Oral Bemiparin Formulations

R

ROVI

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Oral bemiparin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00863577
ROV-BEM-2008-01

Details and patient eligibility

About

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

Enrollment

102 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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