Viewing Study NCT02704702

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 4:03 AM
Ignite Modification Date: 2026-03-02 @ 4:12 AM
Study NCT ID: NCT02704702
Status: COMPLETED
Last Update Posted: 2018-11-02
First Post: 2016-03-04
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558933', 'term': 'fimasartan'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laura.sterling@celerion.com', 'phone': '1-402-476-2811', 'title': 'Dr.Laura Sterling', 'organization': 'Celerion'}, 'certainAgreement': {'otherDetails': 'Obligation of disclosure restriction continue for 3 years from the date of termination or expiration of Agreement effected on November 16th, 2015.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Several sampling time deviations occurred during the clinical conduct of this study. Actual sampling times relative to dosing time were used for caculation of PK parameters.'}}, 'adverseEventsModule': {'timeFrame': 'Participants assessed 13 days for each intervention, a total of approximately 4 weeks', 'description': 'Safety population included all population who receive at least 1 dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A(Single Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 2, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment A(Multiple Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 6, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment B(Single Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 6, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Treatment B(Multiiple Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 7, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Treatment C(Single Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 6, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Treatment C(Multiple Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 8, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Sensory disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Thoracic vertebral fracture', 'notes': 'It is resulted in discontinuation from the study. Approximately 3.4 days following dosing with rosuvastatin 20mg alone, the subject was cutting a tree branch when the branch fell on top of him and he was transported to the hospital via ambulance.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Right clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Right radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'multiple closed rib fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Right sided pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '34', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A(Single Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG001', 'title': 'Treatment A(Multiple Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG002', 'title': 'Treatment B(Single Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG003', 'title': 'Treatment B(Multiple Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG004', 'title': 'Treatment C(Single Dose_Fimasartan)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG005', 'title': 'Treatment C(Single Dose_Rosuvastatin)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG006', 'title': 'Treatment C(Multiple Dose_Fimasartan)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG007', 'title': 'Treatment C(Multiple Dose_Rosuvastatin)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}], 'classes': [{'categories': [{'measurements': [{'value': '690.43', 'groupId': 'OG000', 'lowerLimit': '645.39', 'upperLimit': '809.51'}, {'value': '820.86', 'groupId': 'OG001', 'lowerLimit': '757.50', 'upperLimit': '980.63'}, {'value': '86.442', 'groupId': 'OG002', 'lowerLimit': '82.210', 'upperLimit': '105.59'}, {'value': '114.55', 'groupId': 'OG003', 'lowerLimit': '106.95', 'upperLimit': '138.50'}, {'value': '702.20', 'groupId': 'OG004', 'lowerLimit': '653.05', 'upperLimit': '830.43'}, {'value': '85.078', 'groupId': 'OG005', 'lowerLimit': '78.638', 'upperLimit': '115.45'}, {'value': '880.19', 'groupId': 'OG006', 'lowerLimit': '819.63', 'upperLimit': '1018.7'}, {'value': '98.957', 'groupId': 'OG007', 'lowerLimit': '91.971', 'upperLimit': '120.50'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period', 'description': 'This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '34', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A(Single Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG001', 'title': 'Treatment A(Multiple Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG002', 'title': 'Treatment B(Single Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG003', 'title': 'Treatment B(Multiple Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG004', 'title': 'Treatment C(Single Dose_Fimasartan)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG005', 'title': 'Treatment C(Multiple Dose_Fimasartan)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG006', 'title': 'Treatment C(Single Dose_Rosuvastatin)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG007', 'title': 'Treatment C(Multiple Dose_Rosuvastatin)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}], 'classes': [{'categories': [{'measurements': [{'value': '289.12', 'groupId': 'OG000', 'lowerLimit': '272.28', 'upperLimit': '373.86'}, {'value': '362.14', 'groupId': 'OG001', 'lowerLimit': '339.10', 'upperLimit': '523.63'}, {'value': '9.305', 'groupId': 'OG002', 'lowerLimit': '8.755', 'upperLimit': '11.733'}, {'value': '11.706', 'groupId': 'OG003', 'lowerLimit': '10.927', 'upperLimit': '14.416'}, {'value': '283.73', 'groupId': 'OG004', 'lowerLimit': '268.35', 'upperLimit': '383.63'}, {'value': '341.92', 'groupId': 'OG005', 'lowerLimit': '329.13', 'upperLimit': '462.35'}, {'value': '12.581', 'groupId': 'OG006', 'lowerLimit': '11.697', 'upperLimit': '17.502'}, {'value': '13.687', 'groupId': 'OG007', 'lowerLimit': '12.713', 'upperLimit': '17.300'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period', 'description': 'This Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}, {'value': '34', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A(Single Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG001', 'title': 'Treatment A(Multiple Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG002', 'title': 'Treatment B(Single Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG003', 'title': 'Treatment B(Multiple Dose)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG004', 'title': 'Treatment C(Single Dose_Fimasartan)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG005', 'title': 'Treatment C(Multiple Dose_Fimasartan)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG006', 'title': 'Treatment C(Single Dose_Rosuvastatin)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}, {'id': 'OG007', 'title': 'Treatment C(Multiple Dose_Rosuvastatin)', 'description': 'Sequence 1(ABC)/Sequence 2(ACB)/Sequence 3(BAC)/Sequence 4(BCA)/Sequence 5(CAB)/Sequence 6(CBA)\n\nThere will be a washout of at least 7 days between the each period.\n\nTreatment A: Fimasartan\n\nTreatment B: Rosuvastatin\n\nTreatment C: Fimasartan + Rosuvastatin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.749', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '2.00'}, {'value': '0.635', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '2.51'}, {'value': '2.999', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '5.03'}, {'value': '4.505', 'groupId': 'OG003', 'lowerLimit': '1.01', 'upperLimit': '5.06'}, {'value': '0.750', 'groupId': 'OG004', 'lowerLimit': '0.50', 'upperLimit': '1.50'}, {'value': '0.751', 'groupId': 'OG005', 'lowerLimit': '0.50', 'upperLimit': '4.00'}, {'value': '2.003', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '5.00'}, {'value': '1.506', 'groupId': 'OG007', 'lowerLimit': '1.00', 'upperLimit': '5.09'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period', 'description': 'This Outcome is the time it takes a drug to reach Cmax', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1 (ABC)', 'description': 'Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C)\n\nThere will be a washout of at least 7 days between the each period.\n\nFimasartan\n\nRosuvastatin\n\nFimasartan + Rosuvastatin'}, {'id': 'FG001', 'title': 'Sequence 2 (ACB)', 'description': 'Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B)\n\nThere will be a washout of at least 7 days between the each period.\n\nFimasartan\n\nRosuvastatin\n\nFimasartan + Rosuvastatin'}, {'id': 'FG002', 'title': 'Sequence 3 (BAC)', 'description': 'Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3)\n\nThere will be a washout of at least 7 days between the each period.\n\nFimasartan\n\nRosuvastatin\n\nFimasartan + Rosuvastatin'}, {'id': 'FG003', 'title': 'Sequence 4 (BCA)', 'description': 'Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A)\n\nThere will be a washout of at least 7 days between the each period.\n\nFimasartan\n\nRosuvastatin\n\nFimasartan + Rosuvastatin'}, {'id': 'FG004', 'title': 'Sequence 5 (CAB)', 'description': 'Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B)\n\nThere will be a washout of at least 7 days between the each period.\n\nFimasartan\n\nRosuvastatin\n\nFimasartan + Rosuvastatin'}, {'id': 'FG005', 'title': 'Sequence 6 (CBA)', 'description': 'Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A)\n\nThere will be a washout of at least 7 days between the each period.\n\nFimasartan\n\nRosuvastatin\n\nFimasartan + Rosuvastatin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence 2 (ACB)', 'description': 'Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B)\n\nThere will be a washout of at least 7 days between the each period.\n\nFimasartan\n\nRosuvastatin\n\nFimasartan + Rosuvastatin'}, {'id': 'BG001', 'title': 'Sequence 3 (BAC)', 'description': 'Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3)\n\nThere will be a washout of at least 7 days between the each period.\n\nFimasartan\n\nRosuvastatin\n\nFimasartan + Rosuvastatin'}, {'id': 'BG002', 'title': 'Sequence 1 (ABC)', 'description': 'Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C)\n\nThere will be a washout of at least 7 days between the each period.\n\nFimasartan\n\nRosuvastatin\n\nFimasartan + Rosuvastatin'}, {'id': 'BG003', 'title': 'Sequence 4 (BCA)', 'description': 'Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A)\n\nThere will be a washout of at least 7 days between the each period.\n\nFimasartan\n\nRosuvastatin\n\nFimasartan + Rosuvastatin'}, {'id': 'BG004', 'title': 'Sequence 5 (CAB)', 'description': 'Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B)\n\nThere will be a washout of at least 7 days between the each period.\n\nFimasartan\n\nRosuvastatin\n\nFimasartan + Rosuvastatin'}, {'id': 'BG005', 'title': 'Sequence 6 (CBA)', 'description': 'Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A)\n\nThere will be a washout of at least 7 days between the each period.\n\nFimasartan\n\nRosuvastatin\n\nFimasartan + Rosuvastatin'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-05', 'studyFirstSubmitDate': '2016-03-04', 'resultsFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2016-03-09', 'lastUpdatePostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-05', 'studyFirstPostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve', 'timeFrame': 'For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period', 'description': 'This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method'}, {'measure': 'Maximum Observed Concentration', 'timeFrame': 'For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period', 'description': 'This Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated.'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration', 'timeFrame': 'For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period', 'description': 'This Outcome is the time it takes a drug to reach Cmax'}]}, 'conditionsModule': {'keywords': ['Fimasartan'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.', 'detailedDescription': 'This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Caucasian male 19-55 years of age.\n2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.\n3. Medically healthy with no clinically significant medical history.\n4. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.\n\nExclusion Criteria:\n\n1. History or presence of clinically significant medical or psychiatric condition or disease.\n2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).\n3. Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.\n4. Plasma donation within 7 days prior to the first dose of study drug.\n5. Participation in another clinical trial within 28 days prior to the first dose of study drug(s).'}, 'identificationModule': {'nctId': 'NCT02704702', 'briefTitle': 'A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'orgStudyIdInfo': {'id': 'BR-FRC-CT-102'}, 'secondaryIdInfos': [{'id': 'CA16652', 'type': 'OTHER', 'domain': 'Celerion'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sequence 1 (ABC)', 'description': 'Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C)\n\nThere will be a washout of at least 7 days between the each period.', 'interventionNames': ['Drug: Fimasartan', 'Drug: Rosuvastatin', 'Drug: Fimasartan + Rosuvastatin']}, {'type': 'OTHER', 'label': 'Sequence 2 (ACB)', 'description': 'Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B)\n\nThere will be a washout of at least 7 days between the each period.', 'interventionNames': ['Drug: Fimasartan', 'Drug: Rosuvastatin', 'Drug: Fimasartan + Rosuvastatin']}, {'type': 'OTHER', 'label': 'Sequence 3 (BAC)', 'description': 'Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3)\n\nThere will be a washout of at least 7 days between the each period.', 'interventionNames': ['Drug: Fimasartan', 'Drug: Rosuvastatin', 'Drug: Fimasartan + Rosuvastatin']}, {'type': 'OTHER', 'label': 'Sequence 4 (BCA)', 'description': 'Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A)\n\nThere will be a washout of at least 7 days between the each period.', 'interventionNames': ['Drug: Fimasartan', 'Drug: Rosuvastatin', 'Drug: Fimasartan + Rosuvastatin']}, {'type': 'OTHER', 'label': 'Sequence 5 (CAB)', 'description': 'Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B)\n\nThere will be a washout of at least 7 days between the each period.', 'interventionNames': ['Drug: Fimasartan', 'Drug: Rosuvastatin', 'Drug: Fimasartan + Rosuvastatin']}, {'type': 'OTHER', 'label': 'Sequence 6 (CBA)', 'description': 'Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A)\n\nThere will be a washout of at least 7 days between the each period.', 'interventionNames': ['Drug: Fimasartan', 'Drug: Rosuvastatin', 'Drug: Fimasartan + Rosuvastatin']}], 'interventions': [{'name': 'Fimasartan', 'type': 'DRUG', 'armGroupLabels': ['Sequence 1 (ABC)', 'Sequence 2 (ACB)', 'Sequence 3 (BAC)', 'Sequence 4 (BCA)', 'Sequence 5 (CAB)', 'Sequence 6 (CBA)']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'armGroupLabels': ['Sequence 1 (ABC)', 'Sequence 2 (ACB)', 'Sequence 3 (BAC)', 'Sequence 4 (BCA)', 'Sequence 5 (CAB)', 'Sequence 6 (CBA)']}, {'name': 'Fimasartan + Rosuvastatin', 'type': 'DRUG', 'armGroupLabels': ['Sequence 1 (ABC)', 'Sequence 2 (ACB)', 'Sequence 3 (BAC)', 'Sequence 4 (BCA)', 'Sequence 5 (CAB)', 'Sequence 6 (CBA)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Laura Sterling, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Celelion, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}