Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-03-05 @ 2:50 PM
Study NCT ID:
NCT03010267
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DP-R213 Phase 1 Pharmacokinetics Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020849', 'term': 'Raloxifene Hydrochloride'}], 'ancestors': [{'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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-01', 'studyFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2017-01-04', 'lastUpdatePostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'up to 96 hours post dose'}, {'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'up to 96 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DP-R213'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '36247744', 'type': 'DERIVED', 'citation': 'Lee HW, Kang WY, Gwon MR, Choi EJ, Kim EH, Cho K, Lee B, Seong SJ, Yoon YR. A randomized, open-label, single-dose, two-way crossover study to assess the pharmacokinetics between two tablets of fixed-dose combination formulation with raloxifene and cholecalciferol and concomitant administration of each agents in healthy male volunteers. Transl Clin Pharmacol. 2022 Sep;30(3):136-144. doi: 10.12793/tcp.2022.30.e13. Epub 2022 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* IBW ±20%\n* Signed the informed consent form prior to the study participation\n\nExclusion Criteria:\n\n* Clinically significant disease\n* Previously donate whole blood within 2 months or component blood within 1 month\n* Clinically significant allergic disease\n* Taken IP in other trial within 3 months\n* An impossible one who participates in clinical trial by investigator's decision including laboratory test result"}, 'identificationModule': {'nctId': 'NCT03010267', 'briefTitle': 'DP-R213 Phase 1 Pharmacokinetics Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alvogen Korea'}, 'officialTitle': 'An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Fixed Dose Combination of Raloxifen/Cholecalciferol Compared With Coadministration of Raloxifen and Cholecalciferol in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'DP-CTR213-I-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RT group', 'description': 'combination dose of Raloxifene and Cholecaliferol and DP-R213 in order', 'interventionNames': ['Drug: DP-R213', 'Drug: Raloxifene', 'Drug: Cholecaliferol']}, {'type': 'EXPERIMENTAL', 'label': 'TR group', 'description': 'combination dose of Raloxifene and Cholecaliferol and DP-R213 in order', 'interventionNames': ['Drug: DP-R213', 'Drug: Raloxifene', 'Drug: Cholecaliferol']}], 'interventions': [{'name': 'DP-R213', 'type': 'DRUG', 'description': 'Investigational product is prescribed to all of randomized subjects', 'armGroupLabels': ['RT group', 'TR group']}, {'name': 'Raloxifene', 'type': 'DRUG', 'description': 'Investigational product is prescribed to all of randomized subjects', 'armGroupLabels': ['RT group', 'TR group']}, {'name': 'Cholecaliferol', 'type': 'DRUG', 'description': 'Investigational product is prescribed to all of randomized subjects', 'armGroupLabels': ['RT group', 'TR group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alvogen Korea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}