Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-24 @ 5:14 PM
Study NCT ID:
NCT02704559
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2016-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Explore Drug-drug Interactions Between DWC20155 and DWC20156 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2016-02-27', 'studyFirstSubmitQcDate': '2016-03-05', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': '0~24hr'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': '0~24h'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A randomized, open-label, oral dose, crossover study to explore drug-drug interactions between DWC20155 and DWC20156 in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Accepts healthy volunteers.\n\nExclusion Criteria:\n\n* Who has allergy to investigational product'}, 'identificationModule': {'nctId': 'NCT02704559', 'briefTitle': 'Study to Explore Drug-drug Interactions Between DWC20155 and DWC20156 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'orgStudyIdInfo': {'id': 'DW_DWJ1366001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study effect of DWC20156 on DWC20155 PK', 'description': 'To study effect of DWC20156 on DWC20155 PK', 'interventionNames': ['Drug: DWC20156']}, {'type': 'EXPERIMENTAL', 'label': 'Study effect of DWC20155 on DWC20156 PK', 'description': 'To study effect of DWC20155 on DWC20156 PK', 'interventionNames': ['Drug: DWC20155']}], 'interventions': [{'name': 'DWC20155', 'type': 'DRUG', 'armGroupLabels': ['Study effect of DWC20155 on DWC20156 PK']}, {'name': 'DWC20156', 'type': 'DRUG', 'armGroupLabels': ['Study effect of DWC20156 on DWC20155 PK']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}