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Completed

NCT Number: NCT00863577

Pharmacokinetic Study of Two Oral Bemiparin Formulations

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

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Santa Creu i Sant Pau

Barcelona, 08025, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers: male or female subjects aged between 18 and 45 years
  • Body weight: 65-80 Kg
  • Not meaningful abnormalities in physical examination and in clinical history
  • Without evidence of significant organic or psychiatric illness
  • Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory
  • Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range
  • Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
  • Not give blood in the last 4 weeks.
  • Healthy male volunteers who have not received heparin in the past
  • Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent
  • contraceptive methods double barrel or sterile surgery

Exclusion criteria

  • Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption
  • Important consumption of exciting drinks: alcohol consumption > 30 g/day; coffee, tea, cola > 5 /day
  • Allergy, idiosyncrasy or hypersensitivity to medicines
  • Healthy volunteers who are receiving another medication in the past 15 days
  • Positive serology of hepatitis B, C or HIV
  • Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events
  • Mayor Surgery in the last 6 months
  • Smoking > 10 cigarettes / day
  • Ethanol, cannabis, cocaine, amphetamine, benzodiazepin or opiate in urine
  • Healthy volunteers with a familiar history evident hemorrhagic episodes
  • positive fecatest and comburtest
  • positive pregnant test
  • Bemiparin contraindication

Treatment and study plan

Oral bemiparin

Drug

Bemiparin tablets and bemiparin tablets into hard gelatine capsules

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rovi Pharmaceuticals Laboratories

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Mar 18, 2009
Registry last updated
Mar 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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