Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-09 @ 11:44 PM
Study NCT ID:
NCT01823133
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2013-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C534891', 'term': 'LC15-0444'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-27', 'studyFirstSubmitDate': '2013-03-28', 'studyFirstSubmitQcDate': '2013-03-28', 'lastUpdatePostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'up to 72 hour post dose', 'description': 'to evaluate Cmax of gemigliptin and rosuvastatin at steady state'}, {'measure': 'AUC', 'timeFrame': 'up to 72 hour post dose', 'description': 'to evaluate AUCt of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin at steady state'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': 'up to 72 hour post dose', 'description': 'to evaluate time of Cmax at steady state, gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin'}, {'measure': 'Cmin', 'timeFrame': 'upto 72 hour post dose', 'description': 'to evaluate Cmin of gemigliptin and rosuvastatin at steady state'}, {'measure': 't1/2β', 'timeFrame': 'upto 72 hour post dose', 'description': 'to evaluate half-life of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin'}, {'measure': 'Cmax', 'timeFrame': 'upto 72 hour post dose', 'description': 'to evaluate Cmax of metabolite LC15-0636, N-desmethylrosuvastatin at steady state'}, {'measure': 'AUC', 'timeFrame': 'upto 72 hour post dose', 'description': 'to evaluate AUC of metabolite LC15-0636, N-desmethylrosuvastatin at steady state'}, {'measure': 'metabolic ratio', 'timeFrame': 'upto 72 hour post dose', 'description': 'to evaluate metabolic ratio of gemiglipin and rosuvastatin'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '25350224', 'type': 'DERIVED', 'citation': 'Choi HY, Lim HS, Kim YH, Jeon HS, Kim MJ, Lee SH, Jung JH, Lee YK, Kim HJ, Bae KS. Evaluation of the pharmacokinetics of the DPP-4 inhibitor gemigliptin when coadministered with rosuvastatin or irbesartan to healthy subjects. Curr Med Res Opin. 2015 Feb;31(2):229-41. doi: 10.1185/03007995.2014.980886. Epub 2014 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20 to 45, healthy male subjects (at screening)\n* BMI between 18 - 27 kg/m2 (at screening)\n* Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg\n* FPG 70-125mg/dL glucose level (at screening)\n* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the\n\nExclusion Criteria:\n\n* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)\n* Subject who had GI tract disease that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)\n* Subject who had drug hypersensitivity reaction.(gemigliptin, rosuvastatin, aspirin, antibiotics)\n* Subject who already admitted in other investigator product in 80 days\n* Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently'}, 'identificationModule': {'nctId': 'NCT01823133', 'briefTitle': 'Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': 'A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'LG-GSCL001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'gemigliptin only', 'description': 'Multiple administrations of gemigliptin', 'interventionNames': ['Drug: gemigliptin only']}, {'type': 'EXPERIMENTAL', 'label': 'rosuvastatin only', 'description': 'Multiple administrations of rosuvastatin', 'interventionNames': ['Drug: rosuvastatin only']}, {'type': 'EXPERIMENTAL', 'label': 'gemigliptin and rosuvastatin', 'description': 'Multiple administrations of gemigliptin and rosuvastatin', 'interventionNames': ['Drug: gemigliptin and rosuvastatin']}], 'interventions': [{'name': 'gemigliptin only', 'type': 'DRUG', 'description': 'gemigliptin 50mg qd on day 1\\~7', 'armGroupLabels': ['gemigliptin only']}, {'name': 'rosuvastatin only', 'type': 'DRUG', 'description': 'rosuvastatin 20mg qd on day 1\\~7', 'armGroupLabels': ['rosuvastatin only']}, {'name': 'gemigliptin and rosuvastatin', 'type': 'DRUG', 'description': 'gemigliptin 50mg, rosuvastatin 20mg qd on day 1\\~7', 'armGroupLabels': ['gemigliptin and rosuvastatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Life Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}