Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-04 @ 2:49 PM
Study NCT ID:
NCT02753803
Status:
COMPLETED
Last Update Posted:
2017-09-18
First Post:
2016-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg
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': 'C557982', 'term': '4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'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': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-15', 'studyFirstSubmitDate': '2016-04-25', 'studyFirstSubmitQcDate': '2016-04-25', 'lastUpdatePostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': '1d~6d pre-dose, 15d~20d pre-dose, 29~34d pre-dose, 7d/21d/35d pre-dose and post-dose', 'description': 'area under the concentration-time curve'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects', 'detailedDescription': 'A randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence, crossover study'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Male Volunteers (Age: 19\\~45years)\n* 55\\<Body Weight\\<90, 18\\<BMI\\<27\n* FPG: 70-125 mg/dL\n\nExclusion Criteria:\n\n* galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption\n* Clinically significant Medical History\n* Allergy or Drug Hypersensitivity\n* AST(SGOT), ALT(SGPT) \\> Upper Normal Range\\*1.5, eGFR\\<80 mL/min\n* Drink during clinical trial period\n* Smoking during clinical trial period\n* Grapefruit/Caffeine intake during clinical trial period\n* No Contraception'}, 'identificationModule': {'nctId': 'NCT02753803', 'briefTitle': 'Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg', 'orgStudyIdInfo': {'id': 'DA1229_DIP_I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A group', 'description': 'Evogliptin Pioglitazone Evogliptin+Pioglitazone', 'interventionNames': ['Drug: Evogliptin, Pioglitazone, Evogliptin+Pioglitazone']}, {'type': 'EXPERIMENTAL', 'label': 'B group', 'description': 'Pioglitazone Evogliptin Evogliptin+Pioglitazone', 'interventionNames': ['Drug: Pioglitazone, Evogliptin, Evogliptin+Pioglitazone']}, {'type': 'EXPERIMENTAL', 'label': 'C group', 'description': 'Evogliptin Evogliptin+Pioglitazone Pioglitazone', 'interventionNames': ['Drug: Evogliptin, Evogliptin+Pioglitazone, Pioglitazone']}, {'type': 'EXPERIMENTAL', 'label': 'D group', 'description': 'Pioglitazone Evogliptin+Pioglitazone Evogliptin', 'interventionNames': ['Drug: Pioglitazone, Evogliptin+Pioglitazone, Evogliptin']}, {'type': 'EXPERIMENTAL', 'label': 'E group', 'description': 'Evogliptin+Pioglitazone Evogliptin Pioglitazone', 'interventionNames': ['Drug: Evogliptin+Pioglitazone, Evogliptin, Pioglitazone']}, {'type': 'EXPERIMENTAL', 'label': 'F group', 'description': 'Evogliptin+Pioglitazone Pioglitazone Evogliptin', 'interventionNames': ['Drug: Evogliptin+Pioglitazone, Pioglitazone, Evogliptin']}], 'interventions': [{'name': 'Evogliptin, Pioglitazone, Evogliptin+Pioglitazone', 'type': 'DRUG', 'otherNames': ['Suganon', 'Actos'], 'description': 'Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD', 'armGroupLabels': ['A group']}, {'name': 'Pioglitazone, Evogliptin, Evogliptin+Pioglitazone', 'type': 'DRUG', 'otherNames': ['Suganon', 'Actos'], 'description': 'Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD', 'armGroupLabels': ['B group']}, {'name': 'Evogliptin, Evogliptin+Pioglitazone, Pioglitazone', 'type': 'DRUG', 'otherNames': ['Suganon', 'Actos'], 'description': 'Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD', 'armGroupLabels': ['C group']}, {'name': 'Pioglitazone, Evogliptin+Pioglitazone, Evogliptin', 'type': 'DRUG', 'otherNames': ['Suganon', 'Actos'], 'description': 'Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD', 'armGroupLabels': ['D group']}, {'name': 'Evogliptin+Pioglitazone, Evogliptin, Pioglitazone', 'type': 'DRUG', 'otherNames': ['Suganon', 'Actos'], 'description': 'Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD', 'armGroupLabels': ['E group']}, {'name': 'Evogliptin+Pioglitazone, Pioglitazone, Evogliptin', 'type': 'DRUG', 'otherNames': ['Suganon', 'Actos'], 'description': 'Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD', 'armGroupLabels': ['F group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Clinical Trials Center, Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung-Sang Yu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Trials Center, Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}