- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01692171
Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Intravenous Administration
October 27, 2022 updated by: Azidus Brasil
Pharmacodynamics Study of Enoxalow, Produced by Blau Farmacêutica S/A, Compared to Clexane, Produced by Sanofi-Aventis Farmacêutica Ltda, in Healthy Subjects After Intravenous Administration.
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sao Paulo
-
Valinhos, Sao Paulo, Brazil, 13271-130
- LAL Clínica
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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);
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Teste
Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A.
|
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.
Other Names:
|
Active Comparator: Comparador
Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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.
|
The day after admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 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.
|
The day after admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Márcia Guidone, manager, Blau Farmaceutica S.A.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- FDA 2011. Food and Drug Administration. Draft Guidance on Enoxaparin Sodium.
- 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. Erratum In: J Thromb Haemost. 2007 Jun;5(6):1343.
- 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.
- 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.
- 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.
- Wannmacher L. Heparinas de baixo peso molecular: evidências que fundamentam indicações. Uso Racional de Medicamentos: Temas Selecionados 2007:4:1-6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2013
Primary Completion (Actual)
October 31, 2013
Study Completion (Actual)
October 31, 2013
Study Registration Dates
First Submitted
September 20, 2012
First Submitted That Met QC Criteria
September 24, 2012
First Posted (Estimate)
September 25, 2012
Study Record Updates
Last Update Posted (Actual)
October 31, 2022
Last Update Submitted That Met QC Criteria
October 27, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENOBLA0612IV-I
- Versão 01 datada de 20.06.2012 (Other Identifier: LAL Clinica)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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