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-FXaanti-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
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