Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT03452306
Status:
COMPLETED
Last Update Posted:
2018-07-03
First Post:
2018-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Metformin 750 mg Tablets XR Versus Glucophage® Long 750 mg Tablets XR In Normal Healthy Subjects Under Fasting and Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007863', 'term': 'Lecithin Cholesterol Acyltransferase Deficiency'}, {'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D052456', 'term': 'Hypoalphalipoproteinemias'}, {'id': 'D007009', 'term': 'Hypolipoproteinemias'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'four-way crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-02', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '0 hours (pre-dose), as well as at 0.5, 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 30.0 and 36 hours post-dose', 'description': 'Pharmacokinetics of metformin by Assessment of Observed Maximum Plasma Concentration (Cmax)'}, {'measure': 'AUC(0-t)', 'timeFrame': '0 hours (pre-dose), as well as at 0.5, 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 30.0 and 36 hours post-dose', 'description': 'Pharmacokinetics of metformin by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AUC', 'Cmax', 'Pharmacokinetics', 'metformin', 'fed', 'fasting'], 'conditions': ['Bioequivalence']}, 'descriptionModule': {'briefSummary': 'Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Long Merck )', 'detailedDescription': 'Study to evaluate the bioequivalence of orally administered metformin preparations, Extended release tablets, 750 mg in normal healthy subjects under fasting and fed conditions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent form.\n* Healthy male and female subjects aged 18 to 45 years.\n* Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.\n* Have a body mass index between 18,5 and 27 kg/m2.\n* Females must have a negative pregnancy test.\n* Subjects must use, with their partner, methods of highly effective contraception throughout the study and 30 days after the end of study.\n\nExclusion Criteria:\n\n* History of serious allergic problems/events\n* Medicinal intolerance.\n* History of allergic reactions to memantine or investigator\'s product components\n* Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.\n* Acute infectious diseases in less than 4 weeks before the start of the study.\n* Subjects who have taken medication 4 weeks preceding before the study.\n* Subjects who have taken any drugs known effects on hemodynamics or to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, omeprazole, etc.).\n* Donation of plasma (450 mL or more) within 2 month prior to administration of the study medication.\n* History of significant alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).\n* Smokers.\n* Participation in other clinical training is less than than for 3 months before the study.\n* Lack of signed informed consent form.\n* ECG or vital signs abnormalities (clinically significant).\n* Positive testing for alcohol, drugs, pregnancy.\n* Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before the start of the study.\n* Any diet, for example, vegetarian, for 2 weeks before taking the study medications.\n* Women with preserved reproductive potential who have unprotected sexual intercourse with an unsterilized male partner within 30 days prior to taking the study medication.\n* Heart rate below 60 or above 80 beats per minute.\n* Systolic blood pressure less than 110 mm Hg or more than 139 mm Hg.\n* Diastolic blood pressure less than 70 mm Hg or more than 89 mm Hg.'}, 'identificationModule': {'nctId': 'NCT03452306', 'briefTitle': 'Bioequivalence Study of Metformin 750 mg Tablets XR Versus Glucophage® Long 750 mg Tablets XR In Normal Healthy Subjects Under Fasting and Fed Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Geropharm'}, 'officialTitle': 'Four-way Crossover, Open-label, Single-dose, Bioequivalence Study of Metformin (LLC "GEROPHARM", Russia) 750 mg Tablets Extended Release Versus Glucophage® Long (Merck Santé S.A.S, France) 750 mg Tablets Extended Release in Normal Healthy Subjects Under Fasting and Fed Conditions', 'orgStudyIdInfo': {'id': 'BIOMET-LONG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': 'First aIntervention Period:\n\nSingle administered dose of Metformin (750 mg tablet extended-release in a fasting condition\n\nThird Intervention Period:\n\nSingle administered dose of Metformin (750 mg tablet extended-release) in a fed condition', 'interventionNames': ['Drug: Metformine', 'Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glucophage® Long', 'description': 'Second Intervention Period:\n\nSingle administered dose of Glucophage® ( 750 mg tablet extended-release) in a fasting condition\n\nFourth Intervention Period:\n\nSingle administered dose of Glucophage® ( 750 mg tablet extended-release) in a fed condition', 'interventionNames': ['Drug: Glucophage® Long']}], 'interventions': [{'name': 'Metformine', 'type': 'DRUG', 'otherNames': ['fasting condition'], 'description': 'First aIntervention Period:\n\nSingle administered dose of Metformin (750 mg tablet extended-release) in a fasting condition', 'armGroupLabels': ['Metformin']}, {'name': 'Glucophage® Long', 'type': 'DRUG', 'otherNames': ['fasting condition'], 'description': 'Second Intervention Period:\n\nSingle administered dose of Glucophage® (750 mg tablet extended-release) in a fasting condition', 'armGroupLabels': ['Glucophage® Long']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['fed condition'], 'description': 'Third Intervention Period:\n\nSingle administered dose of Metformin (750 mg tablet extended-release) in a fed condition', 'armGroupLabels': ['Metformin']}, {'name': 'Glucophage® Long', 'type': 'DRUG', 'otherNames': ['fed condition'], 'description': 'Fourth Intervention Period:\n\nSingle administered dose of Metformin (750 mg tablet extended-release) in a fed condition', 'armGroupLabels': ['Glucophage® Long']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150007', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Yarosslavl Clinical Hospital #3', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geropharm', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}