Pharmacokinetic Study of Two Oral Bemiparin Formulations

NCT00863577 | Completed Phase 1

• 1 other identifier: ROV-BEM-2008-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Oral bemiparin DRUG

Bemiparin tablets and bemiparin tablets into hard gelatine capsules

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rovi Pharmaceuticals Laboratories: lead

Study Sites (1)

Hospital Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Interventions

bemiparin

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: March 18, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: March 18, 2011

Record last verified: 2011-03

Locations

ES (1)