Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-02-28 @ 7:10 PM
Study NCT ID:
NCT03321318
Status:
UNKNOWN
Last Update Posted:
2017-10-25
First Post:
2017-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AK-R215 Pharmacokinetic Study Phase I
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C447119', 'term': 'bazedoxifene'}, {'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-01-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-22', 'studyFirstSubmitDate': '2017-07-19', 'studyFirstSubmitQcDate': '2017-10-22', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-t', 'timeFrame': '0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h'}, {'measure': 'Cmax', 'timeFrame': '0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': '0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h'}, {'measure': 'AUCinf,', 'timeFrame': '0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h'}, {'measure': 'T1/2', 'timeFrame': '0, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 60, 72, 96, 120h'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of AK-R215', 'detailedDescription': 'An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the safety and pharmacokinetics characteristics after administration of fixed dose combination or loose combination of AK-R215 in healthy adult male or menopausal female volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BW is above 50kg and BMI is between 18.5 and 30.0\n* Subject who agreed and signed on informed consent form prior to the study participation\n\nExclusion Criteria:\n\n* Presence or history of clinically significant disease\n* Treatment history of any drug which might affect IP within 10days\n* History of other study drugs within 12weeks'}, 'identificationModule': {'nctId': 'NCT03321318', 'briefTitle': 'AK-R215 Pharmacokinetic Study Phase I', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alvogen Korea'}, 'officialTitle': 'AK-R215 Pharmacokinetic Study Pharmacokinetic Characteristics of AK-R215 in Comparison to Each Component Coadministered in Healthy Adult Male or Menopausal Female Valunteers.', 'orgStudyIdInfo': {'id': 'AK-CTR-215-I-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A group', 'description': 'AK-R215, test drug', 'interventionNames': ['Drug: AK-R215', 'Drug: Bazedoxifene 20 mg', 'Drug: Cholecalciferol 800IU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B group', 'description': 'reference drug, Bazedoxifene 20mg, Cholecalciferol 800IU', 'interventionNames': ['Drug: AK-R215', 'Drug: Bazedoxifene 20 mg', 'Drug: Cholecalciferol 800IU']}], 'interventions': [{'name': 'AK-R215', 'type': 'DRUG', 'description': 'Investigational product is prescribed to all ofrandomized subjects', 'armGroupLabels': ['A group', 'B group']}, {'name': 'Bazedoxifene 20 mg', 'type': 'DRUG', 'description': 'Investigational product is prescribed to all of randomized subjects', 'armGroupLabels': ['A group', 'B group']}, {'name': 'Cholecalciferol 800IU', 'type': 'DRUG', 'description': 'Investigational product is prescribed to all of randomized subjects', 'armGroupLabels': ['A group', 'B group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alvogen Korea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}