Pharmacokinetic Study of Two Oral Bemiparin Formulations

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Oral bemiparin

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Hospital Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Rovi Pharmaceuticals Laboratories

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: January 27, 2009
• First Submitted That Met QC Criteria: March 17, 2009
• First Posted (Estimate): March 18, 2009

Study Record Updates

• Last Update Posted (Estimate): March 18, 2011
• Last Update Submitted That Met QC Criteria: March 17, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Healthy volunteers
• Additional Relevant MeSH Terms: Anticoagulants; Bemiparin
• Other Study ID Numbers: ROV-BEM-2008-01