Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT03016494
Status:
UNKNOWN
Last Update Posted:
2017-01-10
First Post:
2017-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics Study of Fixed Dose Combination of DWJ1386 Compared With Co-administration of 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': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'lastUpdateSubmitDate': '2017-01-09', 'studyFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2017-01-09', 'lastUpdatePostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': '0-24 hours'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': '0-24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI≥18.5 and ≤27.0 kg/m2\n* No clinically significant findings\n* Age 19-55 years at screening\n\nExclusion Criteria:\n\n* Who has allergy to investigational product'}, 'identificationModule': {'nctId': 'NCT03016494', 'briefTitle': 'Safety and Pharmacokinetics Study of Fixed Dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Randomized, Open-label, Oral Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Fixed-dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'DW_DWJ1386001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test/Reference Drug', 'description': 'DWJ1386 Tab. followed by co-administration of DWC20155 and DWC20156 Tab.', 'interventionNames': ['Drug: Co-administration of DWC20155 and DWC20156', 'Drug: DWJ1386 Tab.']}, {'type': 'EXPERIMENTAL', 'label': 'Reference/Test Drug', 'description': 'co-administration of DWC20155 and DWC20156 Tab. followed by DWJ1386 Tab.', 'interventionNames': ['Drug: Co-administration of DWC20155 and DWC20156', 'Drug: DWJ1386 Tab.']}], 'interventions': [{'name': 'Co-administration of DWC20155 and DWC20156', 'type': 'DRUG', 'armGroupLabels': ['Reference/Test Drug', 'Test/Reference Drug']}, {'name': 'DWJ1386 Tab.', 'type': 'DRUG', 'armGroupLabels': ['Reference/Test Drug', 'Test/Reference Drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '614-735', 'city': 'Busan', 'state': 'Busanjin-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae-Gook Shin, Professor', 'role': 'CONTACT', 'phone': '82-51-890-6709'}], 'facility': 'Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'centralContacts': [{'name': 'Daewoong Clinical', 'role': 'CONTACT', 'phone': '82-2-550-8106'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}