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

Information source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Heparin, Low-Molecular-Weight (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Official(s) and/or principal investigator(s):
Alexandre Frederico, Principal Investigator, Affiliation: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Overall contact:
Alexandre Frederico, Phone: +55 19 3871-6399, Email: alexandre@lalclinica.com.br

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.

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

anti-FXa

anti-FIIa activity

Secondary outcome:

Tissue Factor Pathway Inhibitor (TFPI)

ratio of anti-FXa and anti-FIIa activity

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 secondary objectives.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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);

- 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.

Locations and Contacts

Alexandre Frederico, Phone: +55 19 3871-6399, Email: alexandre@lalclinica.com.br

LAL Clinica, Valinhos, Sao Paulo 13276-245, Brazil; Not yet recruiting
Alexandre Frederico, Phone: +55 19 38716399, Email: alexandre@lalclinica.com.br
Simone Castro, Phone: +55 19 38716399, Email: simone.castro@lalclinica.com.br
Alexandre Frederico, Principal Investigator
Additional Information

Starting date: March 2013
Last updated: September 24, 2012

Page last updated: August 23, 2015

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