Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Intravenous Administration

This study has been completed.
Sponsor:
Collaborator:
Blau Farmacêutica S.A.
Information provided by (Responsible Party):
Azidus Brasil
ClinicalTrials.gov Identifier:
NCT01692171
First received: September 20, 2012
Last updated: March 3, 2016
Last verified: March 2016
  Purpose
The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following administration of single intravenous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa), as surrogate markers for their circulating concentrations of the drug.

Condition Intervention Phase
Healthy
Drug: Heparin, Low-Molecular-Weight
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacodynamics Study of Enoxalow, Produced by Blau Farmacêutica S/A, Compared to Clexane, Produced by Sanofi-Aventis Farmacêutica Ltda, in Healthy Subjects After Intravenous Administration.

Resource links provided by NLM:


Further study details as provided by Azidus Brasil:

Primary Outcome Measures:
  • Assess the pharmacodynamic profile of the drug test in comparison to the comparator through the measurement of the activity of the Anti-FXa and anti-FIIa markers [ Time Frame: The day after admission ] [ Designated as safety issue: Yes ]
    Post drug administration blood samples were collected at following times - 0; 0:10; 0:20; 0:30; 00:40 12:50; 1; 1:30; two; 2:30; 3; 3:30; 4; 5; 6; 8; 10; 12; 16:24 (± 30) hours after.


Secondary Outcome Measures:
  • Assess the pharmacodynamic profile of the drug test in comparison to the comparator through the measurement of the activity of the TFPI marker and ratio of Anti-FXa and anti-FIIa. [ Time Frame: The day after admission ] [ Designated as safety issue: Yes ]
    Post drug administration blood samples were collected at following times - 0; 0:10; 0:20; 0:30; 00:40 12:50; 1; 1:30; two; 2:30; 3; 3:30; 4; 5; 6; 8; 10; 12; 16:24 (± 30) hours after.


Enrollment: 32
Study Start Date: September 2013
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teste
Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A.
Drug: Heparin, Low-Molecular-Weight
single intravenous administration of 3mg/Kg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.
Other Names:
  • Clexane
  • Enoxalow
Active Comparator: Comparador
Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis
Drug: Heparin, Low-Molecular-Weight
single intravenous administration of 3mg/Kg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.
Other Names:
  • Clexane
  • Enoxalow

Detailed Description:
In addition other pharmacodynamic tests such as Tissue Factor Pathway Inhibitor (TFPI) activity, as well as the ratio of anti-FXa and anti-FIIa activity will be compared as secundary obectives.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Agree to all the purposes of the study by signing and dating the Informed Consent;
  • Male, aged between 18 and 55 years, clinically healthy;
  • BMI between 18.5 and 30;

Exclusion Criteria:

  • Participation in clinical trials in the 12 months preceding the trial;
  • Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
  • Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
  • Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
  • Hemoglobin <13 g/dL;
  • Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory drugs;
  • Use of medications that interact with enoxaparin;
  • History of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism that may interfere with the clinical outcome of the study;
  • History of coagulopathy and bleeding diathesis;
  • Presence of changes in physical examination suggestive of coagulation disorders (bruising, petechiae, or bruising);
  • Body weight < 45 kg or > 100 kg;
  • Absolute platelet count below 100 x 109 / L;
  • History of chronic bleeding;
  • History of acute haemorrhage in the past 30 days;
  • History of sensitivity to mammalian-derived biological products, albumin or any component of the formulation;
  • History of allergy or Steven Johnson disease;
  • Current or previous history (under 12 months) use of illicit drugs and tobacco;
  • History of alcohol abuse, current or previous (within 12 months);
  • At the discretion of the Principal Investigator of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692171

Locations
Brazil
LAL Clinica
Valinhos, Sao Paulo, Brazil, 13271-130
Sponsors and Collaborators
Azidus Brasil
Blau Farmacêutica S.A.
Investigators
Study Director: Márcia Guidone, manager Blau Farmacêutica S.A.
  More Information

Publications:
EMA 2009. European Medicines Agency.Guideline on non-clinical and clinical development of similar biological medical products containing low-molecular-weightheparins:EMEA/CHMP/BMWP/118264/2007.
FDA 2011. Food and Drug Administration. Draft Guidance on Enoxaparin Sodium.
Wannmacher L. Heparinas de baixo peso molecular: evidências que fundamentam indicações. Uso Racional de Medicamentos: Temas Selecionados 2007:4:1-6.

Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT01692171     History of Changes
Other Study ID Numbers: ENOBLA0612IV-I  Versão 01 datada de 20.06.2012 
Study First Received: September 20, 2012
Last Updated: March 3, 2016
Health Authority: Brazil: National Health Surveillance Agency
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Azidus Brasil:
Subjects

Additional relevant MeSH terms:
Calcium heparin
Heparin
Enoxaparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 29, 2016