Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-26 @ 7:39 AM
Study NCT ID:
NCT01825850
Status:
COMPLETED
Last Update Posted:
2014-12-30
First Post:
2013-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C534891', 'term': 'LC15-0444'}, {'id': 'D000077405', 'term': 'Irbesartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-29', 'studyFirstSubmitDate': '2013-04-03', 'studyFirstSubmitQcDate': '2013-04-03', 'lastUpdatePostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax,ss', 'timeFrame': 'up to 72h post-dose', 'description': 'To evaluate Cmax,ss of Gemigliptin and Irbesartan'}, {'measure': 'AUCτ,ss', 'timeFrame': 'up to 72h post-dose', 'description': 'To evaluate AUCτ,ss of Gemigliptin and Irbesartan'}], 'secondaryOutcomes': [{'measure': 'Cmin,ss', 'timeFrame': 'up to 72h post-dose', 'description': 'To evaluate Cmin,ss of Gemigliptin and Irbesartan'}, {'measure': 'Tmax,ss', 'timeFrame': 'up to 72h post-dose', 'description': 'To evaluate Tmax,ss of Gemigliptin, Irbesartan and LC15-0636 (active metaboilite of Gemigliptin)'}, {'measure': 'Cmax,ss', 'timeFrame': 'up to 72h post-dose', 'description': 'To evaluate Cmax,ss of LC15-0636 (active metaboilite of Gemigliptin)'}, {'measure': 'AUCτ,ss', 'timeFrame': 'up to 72h post-dose', 'description': 'To evaluate AUCτ,ss of LC15-0636(active metabolite of Gemigliptin)'}, {'measure': 'metabolic ratio', 'timeFrame': 'up to 72h post-dose', 'description': 'To evaluate metabolic ratio of LC15-0636(active metabolite of Gemigliptin)'}]}, 'oversightModule': {'oversightHasDmc': False}, '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': 'The objective of the study is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alone in healthy male 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* Exclusion 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, irbesartan, 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': 'NCT01825850', 'briefTitle': 'Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Life Sciences'}, 'officialTitle': 'A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Irbesartan in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'LG-GBCL001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gemigliptin', 'description': 'Gemigliptin 50mg q.d. during 7 days', 'interventionNames': ['Drug: Gemigliptin']}, {'type': 'EXPERIMENTAL', 'label': 'Irbesartan', 'description': 'Irbesartan 300mg q.d. during 7 days', 'interventionNames': ['Drug: Irbesartan']}, {'type': 'EXPERIMENTAL', 'label': 'Gemiglitin + Irbesartan', 'description': 'Gemigliptin 50mg + Irbesartan 300mg q.d. during 7 days', 'interventionNames': ['Drug: Gemigliptin', 'Drug: Irbesartan']}], 'interventions': [{'name': 'Gemigliptin', 'type': 'DRUG', 'armGroupLabels': ['Gemigliptin', 'Gemiglitin + Irbesartan']}, {'name': 'Irbesartan', 'type': 'DRUG', 'armGroupLabels': ['Gemiglitin + Irbesartan', 'Irbesartan']}]}, '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'}}}}