Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT02654093
Status:
COMPLETED
Last Update Posted:
2016-03-11
First Post:
2016-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug-drug Interaction Study of DP-R213
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D020849', 'term': 'Raloxifene Hydrochloride'}], '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'}, {'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-10', 'studyFirstSubmitDate': '2016-01-08', 'studyFirstSubmitQcDate': '2016-01-11', 'lastUpdatePostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve(AUCt) of raloxifene', 'timeFrame': '0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours'}, {'measure': 'Peak plasma concentration(Cmax) of raloxifene', 'timeFrame': '0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours'}, {'measure': 'AUCt,corr of cholecalciferol', 'timeFrame': '-20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours'}, {'measure': 'Cmax,corr of cholecalciferol', 'timeFrame': '-20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '34984851', 'type': 'DERIVED', 'citation': 'Lee HW, Kang WY, Jung W, Gwon MR, Cho K, Lee B, Seong SJ, Yoon YR. Pharmacokinetic Drug Interaction Between Raloxifene and Cholecalciferol in Healthy Volunteers. Clin Pharmacol Drug Dev. 2022 May;11(5):623-631. doi: 10.1002/cpdd.1062. Epub 2022 Jan 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about the effect of raloxifene on how the body absorbs and processes cholecalciferol and how cholecalciferol affects raloxifene when they are taken together.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteer, age above 19\n* The result of Ideal Body Weight(IBW) is not less than -20%, no more than +20%\n* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.\n\nExclusion Criteria:\n\n* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment in completion of this clinical study\n* Treatment history of other drugs within last 10 days'}, 'identificationModule': {'nctId': 'NCT02654093', 'briefTitle': 'A Drug-drug Interaction Study of DP-R213', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alvogen Korea'}, 'officialTitle': 'A Randomized, Open-label, Single-dose, 3-period, 6-sequence Crossover Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of Raloxifene, Cholecalciferol in Healthy Korean Male Subjects', 'orgStudyIdInfo': {'id': 'DP-CTR213-I-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'A → B → C / A: Cholecalciferol, B: Raloxifene, C: Cholecalciferol+Raloxifene', 'interventionNames': ['Drug: Cholecalciferol', 'Drug: Raloxifene', 'Drug: Cholecalciferol and Raloxifene co-administration']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'A → C → B', 'interventionNames': ['Drug: Cholecalciferol', 'Drug: Raloxifene', 'Drug: Cholecalciferol and Raloxifene co-administration']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'B → A → C', 'interventionNames': ['Drug: Cholecalciferol', 'Drug: Raloxifene', 'Drug: Cholecalciferol and Raloxifene co-administration']}, {'type': 'EXPERIMENTAL', 'label': 'Group D', 'description': 'B → C → A', 'interventionNames': ['Drug: Cholecalciferol', 'Drug: Raloxifene', 'Drug: Cholecalciferol and Raloxifene co-administration']}, {'type': 'EXPERIMENTAL', 'label': 'Group E', 'description': 'C → A → B', 'interventionNames': ['Drug: Cholecalciferol', 'Drug: Raloxifene', 'Drug: Cholecalciferol and Raloxifene co-administration']}, {'type': 'EXPERIMENTAL', 'label': 'Group F', 'description': 'C → B → A', 'interventionNames': ['Drug: Cholecalciferol', 'Drug: Raloxifene', 'Drug: Cholecalciferol and Raloxifene co-administration']}], 'interventions': [{'name': 'Cholecalciferol', 'type': 'DRUG', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D', 'Group E', 'Group F']}, {'name': 'Raloxifene', 'type': 'DRUG', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D', 'Group E', 'Group F']}, {'name': 'Cholecalciferol and Raloxifene co-administration', 'type': 'DRUG', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D', 'Group E', 'Group F']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41940', 'city': 'Jung-gu', 'state': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungbook National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alvogen Korea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}