NCT01692171

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2013

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

February 28, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2013

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

8 months

First QC Date

September 20, 2012

Last Update Submit

October 27, 2022

Conditions

Healthy

Keywords

Subjects

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    The day after admission

Secondary Outcomes (1)

  • 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.

    The day after admission

Study Arms (2)

Teste

EXPERIMENTAL

Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A.

Drug: Heparin, Low-Molecular-Weight

Comparador

ACTIVE COMPARATOR

Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis

Drug: Heparin, Low-Molecular-Weight

Interventions

Heparin, Low-Molecular-WeightDRUG

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.

Also known as: Clexane, Enoxalow
ComparadorTeste

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAL Clinica

Valinhos, São Paulo, 13271-130, Brazil

Location

Related Publications (9)

  • Bara L, Billaud E, Gramond G, Kher A, Samama M. Comparative pharmacokinetics of a low molecular weight heparin (PK 10 169) and unfractionated heparin after intravenous and subcutaneous administration. Thromb Res. 1985 Sep 1;39(5):631-6. doi: 10.1016/0049-3848(85)90244-0. No abstract available.

    PMID: 4082105BACKGROUND

  • Bruno R, Baille P, Retout S, Vivier N, Veyrat-Follet C, Sanderink GJ, Becker R, Antman EM. Population pharmacokinetics and pharmacodynamics of enoxaparin in unstable angina and non-ST-segment elevation myocardial infarction. Br J Clin Pharmacol. 2003 Oct;56(4):407-14. doi: 10.1046/j.1365-2125.2003.01904.x.

    PMID: 12968985BACKGROUND

  • 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.

    BACKGROUND

  • FDA 2011. Food and Drug Administration. Draft Guidance on Enoxaparin Sodium.

    BACKGROUND

  • Gerotziafas GT, Petropoulou AD, Verdy E, Samama MM, Elalamy I. Effect of the anti-factor Xa and anti-factor IIa activities of low-molecular-weight heparins upon the phases of thrombin generation. J Thromb Haemost. 2007 May;5(5):955-62. doi: 10.1111/j.1538-7836.2007.02477.x.

    PMID: 17461929BACKGROUND

  • Hirsh J, Warkentin TE, Shaughnessy SG, Anand SS, Halperin JL, Raschke R, Granger C, Ohman EM, Dalen JE. Heparin and low-molecular-weight heparin: mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy, and safety. Chest. 2001 Jan;119(1 Suppl):64S-94S. doi: 10.1378/chest.119.1_suppl.64s. No abstract available.

    PMID: 11157643BACKGROUND

  • Kuczka K, Harder S, Picard-Willems B, Warnke A, Donath F, Bianchini P, Parma B, Blume H. Biomarkers and coagulation tests for assessing the biosimilarity of a generic low-molecular-weight heparin: results of a study in healthy subjects with enoxaparin. J Clin Pharmacol. 2008 Oct;48(10):1189-96. doi: 10.1177/0091270008322911. Epub 2008 Aug 20.

    PMID: 18716314BACKGROUND

  • Mousa SA, Bozarth J, Barrett JS. Pharmacodynamic properties of the low molecular weight heparin, tinzaparin: effect of molecular weight distribution on plasma tissue factor pathway inhibitor in healthy human subjects. J Clin Pharmacol. 2003 Jul;43(7):727-34.

    PMID: 12856386BACKGROUND

  • Wannmacher L. Heparinas de baixo peso molecular: evidências que fundamentam indicações. Uso Racional de Medicamentos: Temas Selecionados 2007:4:1-6.

    BACKGROUND

MeSH Terms

Interventions

Heparin, Low-Molecular-WeightEnoxaparin

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Márcia Guidone, manager

    Blau Farmaceutica S.A.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 25, 2012

Study Start

February 28, 2013

Primary Completion

October 31, 2013

Study Completion

October 31, 2013

Last Updated

October 31, 2022

Record last verified: 2022-10

Locations

BR(1)