Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-03 @ 12:35 AM
Study NCT ID:
NCT02670018
Status:
UNKNOWN
Last Update Posted:
2016-02-02
First Post:
2015-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C534891', 'term': 'LC15-0444'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-31', 'studyFirstSubmitDate': '2015-12-22', 'studyFirstSubmitQcDate': '2016-01-29', 'lastUpdatePostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUClast', 'timeFrame': 'up to 48h post-dose', 'description': 'To evaluate AUClast of gemigliptin and metformin'}, {'measure': 'Cmax', 'timeFrame': 'up to 48h post-dose', 'description': 'To evaluate Cmax of gemigliptin and metformin'}], 'secondaryOutcomes': [{'measure': 'Tmax of Gemigliptin, Metformin', 'timeFrame': 'up to 48h post-dose'}, {'measure': 'AUCinf of Gemigliptin, Metformin', 'timeFrame': 'up to 48h post-dose'}, {'measure': 't1/2 of Gemigliptin, Metformin', 'timeFrame': 'up to 48h post-dose'}, {'measure': 'CL/F of Gemigliptin, Metformin', 'timeFrame': 'up to 48h post-dose'}, {'measure': 'Vd/F of Gemigliptin, Metformin', 'timeFrame': 'up to 48h post-dose'}, {'measure': 'AUC0-48h of Gemigliptin metabolite(LC15-0636)', 'timeFrame': 'up to 48h post-dose'}, {'measure': 'Cmax of Gemigliptin metabolite(LC15-0636)', 'timeFrame': 'up to 48h post-dose'}, {'measure': 'Tmax of Gemigliptin metabolite(LC15-0636)', 'timeFrame': 'up to 48h post-dose'}, {'measure': 'AUCinf of Gemigliptin metabolite(LC15-0636)', 'timeFrame': 'up to 48h post-dose'}, {'measure': 't1/2 of Gemigliptin metabolite(LC15-0636)', 'timeFrame': 'up to 48h post-dose'}, {'measure': 'CL/F of Gemigliptin metabolite(LC15-0636)', 'timeFrame': 'up to 48h post-dose'}, {'measure': 'Vd/F of Gemigliptin metabolite(LC15-0636)', 'timeFrame': 'up to 48h post-dose'}, {'measure': 'metabolic ratio(MR) of Gemigliptin metabolite(LC15-0636)', 'timeFrame': 'up to 48h post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets) Administered in Healthy Male Volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 19 to 45, healthy male subjects(at screening)\n* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0\n* FPG 70-125mg/dL glucose level(at screening)\n* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.\n\nExclusion Criteria:\n\n* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)\n* Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)\n* Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)\n* Subject who already participated in other trials in 3months\n* Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.\n* Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)"}, 'identificationModule': {'nctId': 'NCT02670018', 'briefTitle': 'BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': 'A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 Tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg(1000 mg x 2 Tablets) Administered in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'LG-DMCL005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'G+M', 'description': 'Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg \\* 2 tablets', 'interventionNames': ['Drug: gemigliptin and metformin HCl extended release']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'Combination of gemigliptin 25mg/metformin HCl extended release 1000mg \\* 2 tablets', 'interventionNames': ['Drug: gemigliptin/metformin HCl extended release']}], 'interventions': [{'name': 'gemigliptin and metformin HCl extended release', 'type': 'DRUG', 'description': 'Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg \\* 2 tablets, for 1 day', 'armGroupLabels': ['G+M']}, {'name': 'gemigliptin/metformin HCl extended release', 'type': 'DRUG', 'description': 'Administration of combination of gemigliptin 25mg/metformin HCl extended release 1000mg \\* 2 tablets, for 1day', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}