Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT03016520
Status:
UNKNOWN
Last Update Posted:
2017-02-08
First Post:
2017-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety Study of DWJ1392 and DWC20164 in Healthy Male Volunteers
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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2017-01-09', 'lastUpdatePostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': '0-72 hours'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': '0-72 hours'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study to Compare the safety and pharmacokinetics of DWJ1392 and DWC20164 in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically significant findings\n* Age 19-50 years at screening\n\nExclusion Criteria:\n\n* Who has allergy to investigational product'}, 'identificationModule': {'nctId': 'NCT03016520', 'briefTitle': 'Pharmacokinetics and Safety Study of DWJ1392 and DWC20164 in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics and Safety of DWJ1392 and DWC20164 in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'DW_DWJ1392001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test drug', 'description': 'DWJ1392', 'interventionNames': ['Drug: DWJ1392']}, {'type': 'EXPERIMENTAL', 'label': 'Reference drug', 'description': 'DWC20164', 'interventionNames': ['Drug: DWC20164']}], 'interventions': [{'name': 'DWJ1392', 'type': 'DRUG', 'armGroupLabels': ['Test drug']}, {'name': 'DWC20164', 'type': 'DRUG', 'armGroupLabels': ['Reference drug']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Han Seunghoon', 'role': 'CONTACT', 'phone': '82-2-2258-7877'}], 'facility': "Seoul ST. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}