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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2012 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Sponsor:
Information provided by (Responsible Party):
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01692171
First received: September 20, 2012
Last updated: September 24, 2012
Last verified: September 2012
  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 L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • anti-FXa [ Time Frame: 0; 0:10; 0:20; 0:30; 0:40 0:50; 1; 1:30; 2; 2:30; 3; 3:30; 4; 5; 6; 8; 10; 12; 16 e 24 hours after grug administration ] [ Designated as safety issue: Yes ]
  • anti-FIIa activity [ Time Frame: 0; 0:10; 0:20; 0:30; 0:40 0:50; 1; 1:30; 2; 2:30; 3; 3:30; 4; 5; 6; 8; 10; 12; 16 e 24 hours after grug administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tissue Factor Pathway Inhibitor (TFPI) [ Time Frame: 0; 0:10; 0:20; 0:30; 0:40 0:50; 1; 1:30; 2; 2:30; 3; 3:30; 4; 5; 6; 8; 10; 12; 16 e 24 hours after grug administration ] [ Designated as safety issue: Yes ]
  • ratio of anti-FXa and anti-FIIa activity [ Time Frame: 0; 0:10; 0:20; 0:30; 0:40 0:50; 1; 1:30; 2; 2:30; 3; 3:30; 4; 5; 6; 8; 10; 12; 16 e 24 hours after grug administration ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: March 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 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
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

Contacts
Contact: Alexandre Frederico +55 19 38716399 alexandre@lalclinica.com.br

Locations
Brazil
LAL Clinica Not yet recruiting
Valinhos, Sao Paulo, Brazil, 13276-245
Contact: Alexandre Frederico    +55 11 3871-6399    alexandre@lalclinica.com.br   
Principal Investigator: Alexandre Frederico         
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
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: September 24, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Subjects

Additional relevant MeSH terms:
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 28, 2014