Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT01071720
Status:
COMPLETED
Last Update Posted:
2010-12-10
First Post:
2010-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Food on the Pharmacokinetic Characteristics of CKD-501
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C546215', 'term': 'lobeglitazone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-09', 'studyFirstSubmitDate': '2010-02-18', 'studyFirstSubmitQcDate': '2010-02-18', 'lastUpdatePostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the pharmacokinetics of CKD-501 1mg (fed vs. fasting)', 'timeFrame': '0-48 hrs'}], 'secondaryOutcomes': [{'measure': 'To evaluate the safety of CKD-501 1mg from vital signs, physical exam, ECG, laboratory test, adverse event and so on', 'timeFrame': 'Throughout the trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of food on the pharmacokinetic characteristics of CKD-501 in healthy subject.\n\nAnd, secondarily, pharmacokinetic characteristics of the main metabolites will be identified.', 'detailedDescription': 'Healthy volunteers are administrated single-dose (CKD-501 1mg), two treatment(fed vs. fasting), two-period, two sequence crossover.\n\nEvery time before and after each medication, PK parameters and safety of CKD-501 1mg is performed using a blood sample and conducting some tests respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Between 20 aged and 45 aged in healthy adults\n* Weight more than 45kg, IBW 20% within the range\n* Agreement with written informed consent\n\nExclusion Criteria:\n\n* Subject has symptoms of acute disease within 28 days of starting administration of investigational drug\n* Subject with known for history(such as inflammatory gastrointestinal disease, gastric or duodenal ulcer, liver diseases and so on) with affect the ADME of drug\n* Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy disease\n* Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test) within 28 days of starting administration of investigational drug\n* Inadequate result of laboratory test\n\n * AST(SGOT) or ALT(SGPT) \\> 1.25 x upper limit of normal range\n * Total bilirubin \\> 1.5 x upper limit of normal range\n* Clinically significant allergic disease(Except for mild allergic rhinitis seems to be not need for medication)\n* Subject with known for hypersensitivity reactions to glitazone\n* Previously participated in other trial within 60 days\n* Treatment with dug-medicated induction/inhibition metabolic enzyme such as barbiturates within 1 month or with may affect the clinical trial within 10 days\n* Subject takes an abnormal meal which affect the ADME of drug\n* Not able to taking the institutional standard meal\n* Previously make whole blood donation within 60 days or component blood donation within 20 days\n* Continued to be taking caffeine (caffeine \\> 5 cup/day), drinking(alcohol \\> 30 g/day) or during clinical trials can not be drunk or severe heavy smoker (cigarette \\> 10 cigarettes per day)\n* An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result\n* Subject who not practice contraception during clinical trial or pregnant women(including positive pregnancy test) or nursing mothers"}, 'identificationModule': {'nctId': 'NCT01071720', 'acronym': 'CKD-501 FDI', 'briefTitle': 'The Effect of Food on the Pharmacokinetic Characteristics of CKD-501', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Clinical Study to Assess the Effect of Food on the Pharmacokinetic Characteristics of CKD-501 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CKD-19HPS09L'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CKD-501 1mg (fed-fasted group)', 'description': 'CKD-501 1mg should be administered following a high-fat, high-caloric diet(fed condition) in one period and on an empty stomach(fasting condition) in the other period.', 'interventionNames': ['Drug: CKD-501 1mg']}, {'type': 'OTHER', 'label': 'CKD-501 1mg (fasted-fed group)', 'description': 'CKD-501 1mg should be administered on an empty stomach(fasting condition) in one period and following a high-fat, high-caloric diet(fed condition) in the other period.', 'interventionNames': ['Drug: CKD-501 1mg']}], 'interventions': [{'name': 'CKD-501 1mg', 'type': 'DRUG', 'description': 'This study is randomized, balanced, single-dose, two treatment (fed versus fasting), two-period, two sequence crossover design to assess the effects of food on pharmacokinetics profile.', 'armGroupLabels': ['CKD-501 1mg (fasted-fed group)', 'CKD-501 1mg (fed-fasted group)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ji Young Park, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Soo-Yeon Kim/CRA', 'oldOrganization': 'Chong Kun Dang Pharmaceutical'}}}}