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

This study is not yet open for participant recruitment.
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
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 April 17, 2014