Pharmacokinetic Study of Two Oral Bemiparin Formulations

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863577
• Other study ID #: ROV-BEM-2008-01
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2009
• Last updated: March 17, 2011
• Start date: March 2009
• Est. completion date: January 2011

Study information

• Verified date: March 2011
• Source: Rovi Pharmaceuticals Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Rovi Pharmaceuticals Laboratories

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No