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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Heparin, Low-Molecular-Weight

• Registration Number: NCT01692171
• Lead Sponsor: Azidus Brasil

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.

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.

Study Timeline

• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-25
• Study Start: 2013-02-28
• Primary Completion: 2013-10-31
• Study Completion: 2013-10-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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;

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Teste	Heparin, Low-Molecular-Weight	Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A.
Comparador	Heparin, Low-Molecular-Weight	Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis

Primary Outcome Measures

Name	Time	Method
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	The day after admission	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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

LAL Clinica; 🇧🇷 Valinhos, Sao Paulo, Brazil