Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-04-14 @ 12:55 AM
Study NCT ID:
NCT01692158
Status:
COMPLETED
Last Update Posted:
2022-10-31
First Post:
2012-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Subcutaneous Single Dose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2012-09-20', 'studyFirstSubmitQcDate': '2012-09-24', 'lastUpdatePostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anti-FXa', 'timeFrame': '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'}, {'measure': 'anti-FIIa activity', 'timeFrame': '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'}], 'secondaryOutcomes': [{'measure': 'Tissue Factor Pathway Inhibitor (TFPI)', 'timeFrame': '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'}, {'measure': 'ratio of anti-FXa and anti-FIIa activity', 'timeFrame': '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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Agree to all the purposes of the study by signing and dating the Informed Consent;\n* Male, aged between 18 and 55 years, clinically healthy;\n* BMI between 18.5 and 30;\n\nExclusion Criteria:\n\n* Participation in clinical trials in the 12 months preceding the trial;\n* Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;\n* Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;\n* Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;\n* Hemoglobin \\< 13 g/dL;\n* Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory drugs;\n* Use of medications that interact with enoxaparin;\n* History of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism that may interfere with the clinical outcome of the study;\n* History of coagulopathy and bleeding diathesis;\n* Presence of changes in physical examination suggestive of coagulation disorders (bruising, petechiae, or bruising);\n* Changes in the skin or subcutaneous tissue of the place of drug administration(eg liposuction in the abdomen);\n* Absolute platelet count below 100 x 109 / L;\n* History of chronic bleeding;\n* History of acute haemorrhage in the past 30 days;\n* History of sensitivity to mammalian-derived biological products, albumin or any component of the formulation;\n* History of allergy or Steven Johnson disease;\n* Current or previous history (under 12 months) use of illicit drugs and tobacco;\n* History of alcohol abuse, current or previous (within 12 months);\n* At the discretion of the Principal Investigator of the study.'}, 'identificationModule': {'nctId': 'NCT01692158', 'briefTitle': 'Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Subcutaneous Single Dose', 'organization': {'class': 'INDUSTRY', 'fullName': 'Azidus Brasil'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'ENOBLA0512SC-I'}, 'secondaryIdInfos': [{'id': 'Versão 01 datada de 15.05.2012', 'type': 'OTHER', 'domain': 'LAL Clinica'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teste', 'description': 'Enoxalow (Heparin, Low-Molecular-Weight) - Blau Farmacêutica S/A.', 'interventionNames': ['Drug: Heparin, Low-Molecular-Weight']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparador', 'description': 'Clexane (Heparin, Low-Molecular-Weight)- Sanofi-Aventis', 'interventionNames': ['Drug: Heparin, Low-Molecular-Weight']}], 'interventions': [{'name': 'Heparin, Low-Molecular-Weight', 'type': 'DRUG', 'otherNames': ['Clexane', 'Enoxalow'], 'description': '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.', 'armGroupLabels': ['Comparador', 'Teste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13276-245', 'city': 'Valinhos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'LAL Clinica', 'geoPoint': {'lat': -22.97056, 'lon': -46.99583}}], 'overallOfficials': [{'name': 'Alexandre Frederico', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azidus Brasil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azidus Brasil', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}