Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-26 @ 11:58 AM
Study NCT ID:
NCT01341392
Status:
COMPLETED
Last Update Posted:
2011-08-15
First Post:
2011-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-drug Interaction Study(CKD-501, Amlodipine)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C546215', 'term': 'lobeglitazone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-11', 'studyFirstSubmitDate': '2011-04-22', 'studyFirstSubmitQcDate': '2011-04-22', 'lastUpdatePostDateStruct': {'date': '2011-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CKD-501 AUC', 'timeFrame': 'Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr'}, {'measure': 'Amlodipine AUC', 'timeFrame': 'Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr'}], 'secondaryOutcomes': [{'measure': 'CKD-5011 Tmax', 'timeFrame': 'Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24hr'}, {'measure': 'Amlodipine Tmax', 'timeFrame': 'Pre dose(D8-9, D29-30, D50-51), 0, 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 48, 72hr'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug-Drug interaction between the CKD-501 and Amlodipine'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '26163202', 'type': 'DERIVED', 'citation': 'Kim CO, Sil Oh E, Kim C, Park MS. Pharmacokinetic Interaction Between Amlodipine and Lobeglitazone, a Novel Peroxisome Proliferator-activated Receptor-gamma Agonist, in Healthy Subjects. Clin Ther. 2015 Sep;37(9):1999-2006.e1. doi: 10.1016/j.clinthera.2015.06.009. Epub 2015 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the pharmacokinetic drug interaction between CKD-501 and amlodipine after oral administration in healthy male volunteers.', 'detailedDescription': 'Volunteers doses three times over the period of CKD-501 0.5mg or Amlodipine 10mg alone/co-administrate, repeated doses are 10 days.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Between 20 aged and 45 years old in healthy males\n* Body weight ≥ 55kg and 18.5 ≤ IBW \\< 25\n* Agreement with written informed consent\n\nExclusion Criteria:\n\n* Subject has a history affects the ADME of drug\n* Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party\n* Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test)\n* AST,ALT \\> UNL \\* 1.25 or Total bilirubin \\> UNL \\* 1.5\n* Estimated GFR(MDRD) \\< 80\n* SBP \\>150 mmHg, SBP \\< 100 mmHg or DBP \\> 100 mmHg, DBP \\< 60 mmHg or Pulse \\> 100 per/min, Pulse \\< 50 per/min\n* Substance abuse, or a history of drug abuse showed a positive for the party\n* Continued to be taking caffeine (caffeine \\> 5 cup/day), drinking (alcohol \\> 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette \\> 10 cigarettes per day)during clinical trials\n* Medication with drug-mediated induction/inhibition metabolic enzyme within 30 days or with may affect the clinical trial\n* Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking\n* Subject takes grapefruit within 1 month\n* Previously participated in other trial within 60 days\n* Previously donate whole blood within 60 days or component blood within 30 days\n* An impossible one who participates in clinical trial by investigator's decision including laboratory test result"}, 'identificationModule': {'nctId': 'NCT01341392', 'briefTitle': 'Drug-drug Interaction Study(CKD-501, Amlodipine)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Randomized, Open-label, Multiple Dose, Three-treatment, Three-period, Six-sequence Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between CKD-501 and Amlodipine After Oral Administration in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': '19HPS11H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CKD-501 0.5mg', 'description': 'Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.', 'interventionNames': ['Drug: CKD-501']}, {'type': 'EXPERIMENTAL', 'label': 'CKD-501 Amlodipine', 'description': 'Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.', 'interventionNames': ['Drug: CKD-501 amlodipine']}, {'type': 'EXPERIMENTAL', 'label': 'Amlodipine 10mg', 'description': 'Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.', 'interventionNames': ['Drug: amlodiopine']}], 'interventions': [{'name': 'CKD-501', 'type': 'DRUG', 'otherNames': ['Lobeglitazone'], 'description': 'Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.', 'armGroupLabels': ['CKD-501 0.5mg']}, {'name': 'amlodiopine', 'type': 'DRUG', 'description': 'Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.', 'armGroupLabels': ['Amlodipine 10mg']}, {'name': 'CKD-501 amlodipine', 'type': 'DRUG', 'description': 'Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.', 'armGroupLabels': ['CKD-501 Amlodipine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Minsoo Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Severance Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Chin Kim', 'oldOrganization': 'Chong Kun Dang Pharmaceutical'}}}}