Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Subcutaneous Single Dose

Healthy Clinical Trial

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 Subcutaneous Administration.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692158
• Other study ID #: ENOBLA0512SC-I
• Secondary ID: Versão 01 datada
• Status: Completed
• Phase: Phase 1
• Start date: March 2013
• Est. completion date: November 2013

Study information

• Verified date: October 2022
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 subcutaneous 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.

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 secondary objectives.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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);

• Changes in the skin or subcutaneous tissue of the place of drug administration(eg liposuction in the abdomen);

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Heparin, Low-Molecular-Weight
single subcutaneuous administration of 40 mg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.

Locations

Country	Name	City	State
Brazil	LAL Clinica	Valinhos	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Azidus Brasil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti-FXa		0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24h after drug administration
Primary	anti-FIIa activity		0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24 hours after drug administration
Secondary	Tissue Factor Pathway Inhibitor (TFPI)		0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24 hours after drug administration
Secondary	ratio of anti-FXa and anti-FIIa activity		0, 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 4:30, 5, 6, 8, 10, 12, 16, 20 and 24h after drug administration