Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 5:33 PM
Study NCT ID:
NCT01005160
Status:
COMPLETED
Last Update Posted:
2011-01-12
First Post:
2009-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction Between CKD-501 and Metformin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'C546215', 'term': 'lobeglitazone'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-10', 'studyFirstSubmitDate': '2009-10-28', 'studyFirstSubmitQcDate': '2009-10-29', 'lastUpdatePostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CKD - 501 and metformin Pharmacokinetics evaluation', 'timeFrame': '16 days'}], 'secondaryOutcomes': [{'measure': 'CKD-501 and metformin safety evaluation', 'timeFrame': '16 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mellitus, type 2', 'pharmacokinetic evaluation', 'drug interaction between CKD-501 and metformin'], 'conditions': ['Healthy Male Volunteers']}, 'referencesModule': {'references': [{'pmid': '22697273', 'type': 'DERIVED', 'citation': 'Shin D, Kim TE, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Assessment of the pharmacokinetics of co-administered metformin and lobeglitazone, a thiazolidinedione antihyperglycemic agent, in healthy subjects. Curr Med Res Opin. 2012 Jul;28(7):1213-20. doi: 10.1185/03007995.2012.703131. Epub 2012 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety, tolerance by comparing availability and the pharmacokinetic drug interaction between the CKD-501 and metformin when administered alone and combination to healthy male volunteers.', 'detailedDescription': 'Volunteers doses three times over the period of CKD-501 0.5mg and metformin 1000mg alone, repeated doses are five days.\n\nIn addition, the CKD-501 0.5mg and metformin 1000mg are administered simultaneously be used repeatedly to five days.\n\nEvery time before and after each medication safety and drug absorption, distribution, metabolism and excretion rate, and is expected to conduct some tests.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 20 aged and 45 aged in healthy males\n* Weight more than 55kg, IBW 20% within the range\n* FPG 70\\~125 mg/dL\n* Agreement with written informed consent\n\nExclusion Criteria:\n\n* Clinically significant disease(liver, heart, immune system, Respiratory system, Endocrine system, blood tumor disease, Mental illness)or a history that has learned\n* Test drug may affect the absorption of the gastrointestinal disease or a history that has learned\n* Hypersensitivity reactions to drugs or Clinically significant hypersensitivity reactions in the history of party\n* AST, ALT level over to 1.5 times and creatinine clearance less 80mL/min\n* systolic blood pressure less than 100mmHg or 150mmHg, diastolic blood pressure less than 60mmHg or greater than 95mmHg\n* Substance abuse, or a history of drug abuse showed a positive for the party\n* Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking\n* Previously participated in other trial within 2 months\n* Medication within 2 months make whole blood donation or medication within 1 month in component blood donation\n* Continued to be drunk or during clinical trials can not be drunk\n* 10 cigarettes a day for the last 3 months than the average smoker or during clinical trials can not be smoke\n* Containing grapefruit foods ingested during clinical trials or can not be ingested\n* Containing caffeine foods ingested during 24 hours before admission to hospital of can not be ingested'}, 'identificationModule': {'nctId': 'NCT01005160', 'acronym': 'CKD-19HPS09H', 'briefTitle': 'Drug Interaction Between CKD-501 and Metformin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Sequence-randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Metformin After Oral Administration in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'CKD-19HPS09H'}, 'secondaryIdInfos': [{'id': '19HPS09H'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CKD501', 'interventionNames': ['Drug: Metformin', 'Drug: CKD-501']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Lobeglitazone'], 'description': 'CKD-501 0.5mg, metformin 1000mg', 'armGroupLabels': ['CKD501']}, {'name': 'CKD-501', 'type': 'DRUG', 'otherNames': ['Lobeglitazone'], 'description': 'CKD-501 0.5mg, metformin 1000mg', 'armGroupLabels': ['CKD501']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kyung S Yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chin Kim', 'oldOrganization': 'Chong Kun Dang'}}}}