Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 12:08 AM
Study NCT ID:
NCT04070794
Status:
UNKNOWN
Last Update Posted:
2019-08-28
First Post:
2019-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C534891', 'term': 'LC15-0444'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-25', 'studyFirstSubmitDate': '2019-08-21', 'studyFirstSubmitQcDate': '2019-08-25', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of gemigliptin, LC 15-0636 and metformin', 'timeFrame': 'Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose.', 'description': 'The observed maximum or peak concentration after administration of the drug'}, {'measure': 'AUC0-tlast of gemigliptin, LC 15-0636 and metformin', 'timeFrame': 'Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose.', 'description': 'Area under the concentration-time curve from time zero to the last time where plasma concentration can be measured'}, {'measure': 'AUC0-∞ of gemigliptin, LC 15-0636 and metformin', 'timeFrame': 'Blood samples (10 mL each) will be collected at time 0.00 (pre-dose; 2x10 mL in duplicate tubes) and at 0.25, 0.50, 1.00, 1.50, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 24.00 and 48.00 hours post-dose.', 'description': 'Area under the concentration-time curve from time zero to infinity by the extrapolation of the rest of AUC from last time where plasma concentration can be measured to time infinity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes']}, 'descriptionModule': {'briefSummary': 'A randomized, open-label, single oral dose, one-treatment, two-period, two-sequence, crossover bioavailability study under fed and fasting conditions in healthy Thai volunteers with at least 7 days washout period between the administrations of investigational products of two consecutive periods.\n\nA: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once without food (fasting conditions) B: Fixed dose combination Zemimet® SR Tab. 50/1000 mg orally administered once with food (fed conditions)', 'detailedDescription': '\\[Objectives\\] Primary: To investigate the food-effect bioavailability of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab. 50/1000 mg) in healthy subjects under fed and fasting conditions Secondary: To evaluate safety of investigational product under fed and fasting conditions\n\n\\[Admission and Confinement\\] Fed conditions: Subjects will be admitted the night before investigational product administration, supervised for at least 8 hours overnight fasting prior to consume standard HFHC breakfast and in-house stay until 24 hours post-dose.\n\nFasting conditions: Subjects will be admitted a night before investigational product administration, supervised for at least 8 hours overnight fasting prior to dosing and in-house stay until 24 hours post-dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index between 18.0 to 30.0 kg/m2.\n* Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening.\n* Non-pregnant woman (negative pregnancy test) and not currently breast feeding.\n* Female subjects abstain from either hormonal methods of contraception\n* Male subjects who are willing or able to use effective contraceptive\n* Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study\n\nExclusion Criteria:\n\n* History serious hypersensitivity reactions\n* History or evidence of clinically significant diseases or any significant ongoing chronic medical illness\n* History or evidence of family diabetes\n* History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis, diabetic pre-coma\n* History or evidence of shock or severe dehydrate or severe infection such as respiratory tract infection, urinary tract infection within 14 days prior to admission in each period\n* History or evidence of preceding diarrhea or vomiting within 24 hours prior to admission in each period\n* History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse\n* History of problems with swallowing tablet or capsule\n* Difficulty fasting or consuming standardized meals\n* History of sensitivity to heparin or heparin-induced thrombocytopenia\n* Any condition possibly affecting drug absorption\n* Have renal creatinine clearance (Clcr) \\< 45 mL/min based on serum creatinine results at the screening laboratory test\n* 12-lead ECG demonstrating QTc \\>450 msec, a QRS interval \\>120 msec or with an abnormality considered clinically significant at screening.'}, 'identificationModule': {'nctId': 'NCT04070794', 'briefTitle': 'Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg Under Fed and Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Chem'}, 'officialTitle': 'A Randomized, Open-label, Single-dose, Two-way Crossover Study to Investigate Food-effect Bioavailability of Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) Under Fed and Fasting Conditions in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'LG-DMCL008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FDC Zemimet® SR Tab. 50/1000(Fasting)', 'description': 'Gemigliptin/Metformin Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) under fasting condition', 'interventionNames': ['Drug: Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FDC Zemimet® SR Tab. 50/1000(Fed)', 'description': 'Gemigliptin/Metformin Fixed Dose Combination Zemimet® SR Tab. 50/1000 mg (Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg) under fed condition', 'interventionNames': ['Drug: Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)']}], 'interventions': [{'name': 'Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting)', 'type': 'DRUG', 'description': 'Fasting conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water after an overnight fasting for at least 8 hours.', 'armGroupLabels': ['FDC Zemimet® SR Tab. 50/1000(Fasting)']}, {'name': 'Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)', 'type': 'DRUG', 'description': 'Fed conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water at 30 minutes after the start of standardized HFHC breakfast.', 'armGroupLabels': ['FDC Zemimet® SR Tab. 50/1000(Fed)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eunjoo Cho', 'role': 'CONTACT', 'email': 'eunjoo.cho@lgchem.com', 'phone': '+82-2-6987-4284'}, {'name': 'Sirin Khantichaikajon', 'role': 'CONTACT', 'email': 'sirink@lgchem.com', 'phone': '+66-2-654-2323', 'phoneExt': '118'}], 'overallOfficials': [{'name': 'Uthai Suvanakoot', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Bio Service Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Chem', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}