Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT04185805
Status:
UNKNOWN
Last Update Posted:
2019-12-06
First Post:
2019-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety of DWP14012 Tablet A and Tablet B in Healthy Volunteers (III)
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': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-04', 'studyFirstSubmitDate': '2019-12-03', 'studyFirstSubmitQcDate': '2019-12-03', 'lastUpdatePostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCt: Area under the drug concentration-time curve from time 0 to tau (dosing interval)', 'timeFrame': '0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour', 'description': 'each period'}, {'measure': 'Cmax: Peak concentration of DWP14012', 'timeFrame': '0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour', 'description': 'each period'}], 'secondaryOutcomes': [{'measure': 'AUCinf: Area under the drug concentration-time curve from time 0 to infinity', 'timeFrame': '0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour', 'description': 'each period'}, {'measure': 'Tmax: Time of maximum concentration', 'timeFrame': '0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour', 'description': 'each period'}, {'measure': 't1/2: Terminal elimination half-life', 'timeFrame': '0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour', 'description': 'each period'}, {'measure': 'CL/F: Apparent Clearance', 'timeFrame': '0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour', 'description': 'each period'}, {'measure': 'Vd/F: Apparent volume of distribution', 'timeFrame': '0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour', 'description': 'each period'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, single dose study to evaluate the safety and pharmacokinetics of DWP14012 tablet A and DWP14012 tablet B in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adult aged between 19 and 45 at screening\n* Those whose weight is 55 kg and more and BMI is between 17.5 and 30.5 kg/m2\n* Subjects who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc\n\nExclusion Criteria:\n\n* Subjects who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history\n* Subjects who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)\n* Subjects who showed positive result for Helicobacter pylori test\n* Subjects with serum AST (SGOT) or ALT (SGPT) level \\>1.5 times the upper limit of the normal range at the time of the screening examination\n* Subjects with a history of drug abuse or a positive urine screening for drug abuse\n* Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration\n* Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration"}, 'identificationModule': {'nctId': 'NCT04185805', 'briefTitle': 'Pharmacokinetics and Safety of DWP14012 Tablet A and Tablet B in Healthy Volunteers (III)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Randomized, Open-label, Single Dose Study to Evaluate the Safety and Pharmacokinetics of DWP14012 Tablet A and DWP14012 Tablet B in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'DW_DWP14012103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1 (Tablet B - Tablet A)', 'description': 'Period 1 : DWP14012 tablet B Period 2: DWP14012 tablet A', 'interventionNames': ['Drug: DWP14012 tablet A', 'Drug: DWP14012 tablet B']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2 (Tablet A - Tablet B)', 'description': 'Period 1 : DWP14012 tablet A Period 2: DWP14012 tablet B', 'interventionNames': ['Drug: DWP14012 tablet A', 'Drug: DWP14012 tablet B']}], 'interventions': [{'name': 'DWP14012 tablet A', 'type': 'DRUG', 'description': 'Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A', 'armGroupLabels': ['Sequence 1 (Tablet B - Tablet A)', 'Sequence 2 (Tablet A - Tablet B)']}, {'name': 'DWP14012 tablet B', 'type': 'DRUG', 'description': 'Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B', 'armGroupLabels': ['Sequence 1 (Tablet B - Tablet A)', 'Sequence 2 (Tablet A - Tablet B)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Anhye Kim', 'role': 'CONTACT', 'email': 'ankim1@cha.ac.kr', 'phone': '82-31-780-4933'}], 'facility': 'Bundang CHA Medical Center', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}