Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-02-22 @ 7:23 AM
Study NCT ID:
NCT04114461
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2019-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate HL-TOF Tab. 5 mg Compared With XelJanz Tab. in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '2X2'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-10', 'studyFirstSubmitDate': '2019-10-02', 'studyFirstSubmitQcDate': '2019-10-02', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour', 'description': 'Maximum concentration'}, {'measure': 'AUC', 'timeFrame': '0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour', 'description': 'Area under curve'}], 'secondaryOutcomes': [{'measure': 'AE', 'timeFrame': '0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour', 'description': 'Number of participants with adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and pharmacokinetics of HL-TOF tab. 5 mg compared with those of XelJanz tab. in healthy volunteers', 'detailedDescription': 'The purpose of this study is to evaluate the safety and pharmacokinetics of tofacitinib after single oral administration of Xeljanz tab. 5mg as reference drug and HL-TOF tab. 5mg as test drug in healthy voluteers. AUC and Cmax would be evaluated for the pharmacokinetics. Adverse event, Laboratory examination and other examination result would be evaluated for the safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Years 19-60\n* No pathological symptoms or findings\n* Suitable for the criteria for examination\n* 90≤SBP≤139, 60≤DBP≤89\n* Body weight≥50kg (Female≥45kg) and 18≤BMI≤30kg/m2\n* Contraceptive during the study period\n* Volunteer for the study and sign to ICF\n\nExclusion Criteria:\n\n* Subject with medical history which affect on the absorption of drug\n* Following condition: Mental illness, Hepatic disorder, Tuberculosis, ANC\\< 500cells/mm3, ALC\\<500cells/mm3, Hb\\<8g/dL\n* Subject with hypersensitivity reaction to HL-TOF and Xeljanz\n* Subject with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption\n* Subject who take a vaccination within 30 days\n* Subject who take a medication such as barbiturates within 30 days\n* Subject who take a medication that affect to the pharmacokinetics of drug within 10 days\n* Subject who take alcohol more than 21 cups per week\n* Subject who smoke 20 cigarettes per day\n* Subject who participate in any clinical investigation within 6 month prior to study medication dosing\n* Subject with whole blood donation within 60 days, component blood donation within 14 days, blood donation within 30 days\n* Subject with decision of non-participation through investigator's review"}, 'identificationModule': {'nctId': 'NCT04114461', 'briefTitle': 'Study to Evaluate HL-TOF Tab. 5 mg Compared With XelJanz Tab. in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanlim Pharm. Co., Ltd.'}, 'officialTitle': 'An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of HL-TOF Tab. 5 mg Compared With Those of XelJanz Tab. in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'HL-TOF-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HL-TOF tab. 5mg', 'description': 'Tofacitinib freebase', 'interventionNames': ['Drug: HL-TOF tab. 5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xeljanz tab. 5mg', 'description': 'Tofacitinib citrate (5mg as tofacitinib)', 'interventionNames': ['Drug: Xeljanz tab. 5mg']}], 'interventions': [{'name': 'HL-TOF tab. 5mg', 'type': 'DRUG', 'otherNames': ['Tofacitinib freebase'], 'description': 'HL-TOF', 'armGroupLabels': ['HL-TOF tab. 5mg']}, {'name': 'Xeljanz tab. 5mg', 'type': 'DRUG', 'otherNames': ['Tofacitinib citrate'], 'description': 'Xeljanz', 'armGroupLabels': ['Xeljanz tab. 5mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'YANGJI Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'JAEWOO KIM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H Plus Yangji Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanlim Pharm. Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}