Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-26 @ 10:32 AM
Study NCT ID:
NCT02537405
Status:
COMPLETED
Last Update Posted:
2015-09-01
First Post:
2015-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004617', 'term': 'Embolism'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013927', 'term': 'Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-28', 'studyFirstSubmitDate': '2015-08-28', 'studyFirstSubmitQcDate': '2015-08-28', 'lastUpdatePostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (maximum observed drug concentration in measured matrix after single dose administration)', 'timeFrame': 'Multiple time point up to 3 day'}, {'measure': 'AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation))', 'timeFrame': 'Multiple time point up to 3 day'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events as a measure of safety and tolerability', 'timeFrame': 'Up to 30 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Embolism, Atrial Fibrillation and Venous Thrombosis']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of rivaroxaban 10mg in healthy adult male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Japanese healthy male subjects\n* 20 to 40 years of age\n* 17.6 to 26.4 kg / m² of body mass index (BMI)\n\nExclusion Criteria:\n\n* Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal\n* Subject with a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction\n* Subject with known coagulation disorders (eg von Willebrand's disease, hemophilia)\n* Subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer)\n* Subject with known sensitivity to common causes of bleeding (eg nasal)"}, 'identificationModule': {'nctId': 'NCT02537405', 'briefTitle': 'Bioequivalence Study of Rivaroxaban in Japanese Healthy Adult Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 10 mg and a Rivaroxaban Granule 10 mg in Japanese Healthy Adult Male Subjects', 'orgStudyIdInfo': {'id': '17018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY59-7939 granule', 'interventionNames': ['Drug: Rivaroxaban (BAY 59-7939)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BAY59-7939 tablet', 'interventionNames': ['Drug: Rivaroxaban (Xarelto, BAY 59-7939)']}], 'interventions': [{'name': 'Rivaroxaban (BAY 59-7939)', 'type': 'DRUG', 'description': 'Rivaroxaban granule 10mg for one day', 'armGroupLabels': ['BAY59-7939 granule']}, {'name': 'Rivaroxaban (Xarelto, BAY 59-7939)', 'type': 'DRUG', 'description': 'Rivaroxaban tablet 10mg for one day', 'armGroupLabels': ['BAY59-7939 tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '861-4157', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}