Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-04-17 @ 3:17 PM
Study NCT ID:
NCT02185066
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2014-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-28', 'studyFirstSubmitDate': '2014-07-07', 'studyFirstSubmitQcDate': '2014-07-07', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) of Atorvastatin', 'timeFrame': 'Upto 36 hours'}, {'measure': 'Maximum plasma concentration (Cmax) of Metformin', 'timeFrame': 'Upto 24 hours'}, {'measure': 'Area Under the plasma concentration-time Curve (AUC0-t) of Atorvastatin', 'timeFrame': 'Upto 36 hours'}, {'measure': 'Area Under the plasma concentration-time Curve (AUC0-t) of Metformin', 'timeFrame': 'Upto 24 hours'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) of 2-OH-atorvastatin', 'timeFrame': 'Upto 36 hours'}, {'measure': 'Area Under the plasma concentration-time Curve (AUC0-t) of 2-OH-atorvastatin', 'timeFrame': 'Upto 36 hours'}, {'measure': 'CL/F of Atorvastatin and Metformin', 'timeFrame': 'Upto 36 hours'}, {'measure': 'Vd/F of Atorvastatin and Metformin', 'timeFrame': 'Upto 36 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin and metformin XR, in healthy volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing to adhere to protocol requirements and sign a informed consent form\n2. Male volunteers in the age between 19 and 55 years old and have the weight range is not exceed ±20% of ideal weight\n3. Subjects with no history of any significant chronic disease\n4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data\n\nExclusion Criteria:\n\n1. Use of barbital inducer or inhibitor medication within the 4 weeks before dosing\n2. Symptom of an acute illness within 4 weeks prior to drug administration\n3. History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME\n4. History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines\n5. History of clinically significant allergies including drug allergies\n6. History of clinically significant allergies about atorvastatin or metformin\n7. Subjects who have ever or have plan to do intravenous injection of contrast medium (intravenous urography, intravenous cholangiography, computed tomography using contrast medium) within 28 days prior to drug administration\n8. History of myopathy\n9. Clinical laboratory test values are outside the accepted normal range\n\n * AST or ALT \\>1.25 times to normal range\n * Total bilirubin \\>1.5 times to normal range\n * e-GFR \\<90 mL/min\n10. History of drug, caffein(caffein \\> 5 cups/day), smoking (cigarette \\> 10/day) or alcohol abuse(alcohol \\> 30 g/day)or Subjects who have ever drink within 7 days prior to drug administration\n11. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration\n12. Donated blood within 60 days prior to dosing\n13. Participated in a previous clinical trial within 60 days prior to dosing\n14. Use of any other medication, including herbal products, within 10 days before dosing\n15. Subjects considered as unsuitable based on medical judgement by investigators'}, 'identificationModule': {'nctId': 'NCT02185066', 'briefTitle': 'Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR', 'organization': {'class': 'INDUSTRY', 'fullName': 'HK inno.N Corporation'}, 'orgStudyIdInfo': {'id': 'CJ_ATM_103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Single-dose crossover\n\n1. Reference: Atorvastatin 20mg and Metformin XR 500mg\n2. Test: CJ-30056 20/500mg\n\nOnce daily Oral administration with 7days of washout period', 'interventionNames': ['Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference)', 'Drug: CJ-30056 20/500mg (Test)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Single-dose crossover\n\n1. Test: CJ-30056 20/500mg\n2. Reference: Atorvastatin 20mg and Metformin XR 500mg\n\nOnce daily Oral administration with 7days of washout period', 'interventionNames': ['Drug: Atorvastatin 20mg and Metformin XR 500mg (Reference)', 'Drug: CJ-30056 20/500mg (Test)']}], 'interventions': [{'name': 'Atorvastatin 20mg and Metformin XR 500mg (Reference)', 'type': 'DRUG', 'description': 'Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.\n\nGroup 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'CJ-30056 20/500mg (Test)', 'type': 'DRUG', 'description': 'Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.\n\nGroup 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between.', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje University Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'Jong-lyul Ghim, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HK inno.N Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}