Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-02-05 @ 6:14 AM
Study NCT ID:
NCT02088918
Status:
COMPLETED
Last Update Posted:
2014-03-17
First Post:
2014-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared With a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet Under Fasting Conditions in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077715', 'term': 'Nateglinide'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2014-03-14', 'studyFirstSubmitDate': '2014-03-13', 'studyFirstSubmitQcDate': '2014-03-14', 'lastUpdatePostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC last', 'timeFrame': '0-~24hrs'}, {'measure': 'Cmax', 'timeFrame': '0~24hrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'A Randomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared with a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet under Fasting Conditions in Healthy Male Subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20 and 40\n* Signed informed consent\n\nExclusion Criteria:\n\n* Has a history of hypersensitivity to IP ingredients\n* Hypertension or hyportension'}, 'identificationModule': {'nctId': 'NCT02088918', 'briefTitle': 'A Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared With a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet Under Fasting Conditions in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'IlDong Pharmaceutical Co Ltd'}, 'orgStudyIdInfo': {'id': 'ID_Fasticmet_1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nateglinide+Metformin', 'description': 'coadministration of nateglinide and metformin', 'interventionNames': ['Drug: Nateglinide', 'Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Nateglinide/Metformin', 'description': 'Nateglinide/Metformin tablet', 'interventionNames': ['Drug: Nateglinide/Metformin']}], 'interventions': [{'name': 'Nateglinide', 'type': 'DRUG', 'armGroupLabels': ['Nateglinide+Metformin']}, {'name': 'Nateglinide/Metformin', 'type': 'DRUG', 'armGroupLabels': ['Nateglinide/Metformin']}, {'name': 'Metformin', 'type': 'DRUG', 'armGroupLabels': ['Nateglinide+Metformin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IlDong Pharmaceutical Co Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}