Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-11 @ 5:44 PM
Study NCT ID:
NCT03121820
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2017-04-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008559', 'term': 'Memantine'}], 'ancestors': [{'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'inform@geropharm.ru', 'phone': '+7(812) 703-79-75', 'title': 'GEROPHARM Clinical Leader', 'organization': 'GEROPHARM'}, 'certainAgreement': {'otherDetails': 'If a publication (e.g., in a scientific journal) based on the results of this study is envisaged, approval from GEROPHARM will be obtained and a draft manuscript will be submitted to GEROPHARM for scrutiny and comment. The choice of conduit will be mutually agreed on by the Principal Investigator and GEROPHARM.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Memantinol Tablets, 20 mg', 'description': 'Active experimental drug\n\nMemantinol: Single orally administered dose of Memantinol (20 mg memantine) in a fasting state', 'otherNumAtRisk': 18, 'otherNumAffected': 2, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Akatinol Memantine® Tablets, 20 mg', 'description': 'Active comparator\n\nAkatinol Memantine®: Single orally administered dose of Akatinol Memantine® (20 mg memantine) in a fasting state', 'otherNumAtRisk': 18, 'otherNumAffected': 2, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'notes': 'The volunteers during period, 2.5 hours after taking the test drug (20 mg orally) was dizzy. Deviations in any Analyzed indicators were not revealed. There was no volunteer Action taken. AE resolved full recovery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics of Memantinol by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantinol Tablets, 20 mg', 'description': 'Treatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC "GEROPHARM", Russia - test)\n\nMemantinol tablets, 20 mg: Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition'}, {'id': 'OG001', 'title': 'Akatinol Memantine® Tablets, 20 mg', 'description': 'Treatment B: a single oral dose of memantin 20 mg film-coated tablet (Merz Pharma GmbH \\& Co. KGaA, Germany - reference)\n\nAkatinol Memantine® tablets, 20 mg: Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH \\& Co. KGaA, Germany) 20 mg film-coated tablets fasting condition'}], 'classes': [{'categories': [{'measurements': [{'value': '1920.362', 'spread': '449.289', 'groupId': 'OG000'}, {'value': '2096.669', 'spread': '537.147', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Test/Ref Geometric mean ratio x 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '93.8', 'ciLowerLimit': '88.25', 'ciUpperLimit': '99.77', 'groupDescription': 'Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg', 'statisticalMethod': 'Test/Ref Geometric mean ratio x 100', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.', 'nonInferiorityComment': 'The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), as well as at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose', 'description': 'Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf), of memantinol sourced in Memantinol® (JSC "GEROPHARM", Russia) and Akatinol Memantine® (Merz Pharma GmbH \\& Co. KGaA, Germany)', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics of Memantinol by Assessment of Observed Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memantinol Tablets, 20 mg', 'description': 'Treatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC "GEROPHARM", Russia - test)\n\nMemantinol tablets, 20 mg: Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition'}, {'id': 'OG001', 'title': 'Akatinol Memantine® Tablets, 20 mg', 'description': 'Treatment B: a single oral dose of memantin 20 mg film-coated tablet (Merz Pharma GmbH \\& Co. KGaA, Germany - reference)\n\nAkatinol Memantine® tablets, 20 mg: Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH \\& Co. KGaA, Germany) 20 mg film-coated tablets fasting condition'}], 'classes': [{'categories': [{'measurements': [{'value': '34.617', 'spread': '8.302', 'groupId': 'OG000'}, {'value': '37.578', 'spread': '8.858', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Test/Ref Geometric mean ratio x 100', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.3', 'ciLowerLimit': '86.37', 'ciUpperLimit': '98.55', 'groupDescription': 'Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg', 'statisticalMethod': 'Test/Ref Geometric mean ratio x 100', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.', 'nonInferiorityComment': 'The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 hours (pre-dose), as well as at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose', 'description': 'Comparison of the pharmacokinetic profile in terms of observed maximum plasma concentration, taken directly from the individual concentration-time curve, Cmax, of memantinol sourced in Memantinol® (JSC "GEROPHARM", Russia) and Akatinol Memantine® (Merz Pharma GmbH \\& Co. KGaA, Germany)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Memantinol First, Then Akatinol Memantine®', 'description': 'First Intervention Period (3 day):\n\nMemantinol tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state\n\n(21 day washout period)\n\nSecond Intervention Period (3 day):\n\nAkatinol Memantine® tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state'}, {'id': 'FG001', 'title': 'Akatinol Memantine® First, Then Memantinol', 'description': 'First Intervention Period (3 day):\n\nAkatinol Memantine® tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state\n\n(21 day washout period)\n\nSecond Intervention Period (3 day):\n\nMemantinol tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state'}], 'periods': [{'title': 'First Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Period (After Washout)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants recruited at GKB № 15 im. O. M. Filatova Public Healthcare Institution of Department of health care of Moscow, Russian Federation between October and November 2016', 'preAssignmentDetails': '18 participants recruited; 25 screened, 7 excluded (5 did not meet inclusion criteria and 2 refused participation).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Memantinol First, Then Akatinol Memantine®', 'description': 'First Intervention Period (3 day):\n\nMemantinol tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state\n\n(21 day washout period)\n\nSecond Intervention Period (3 day):\n\nAkatinol Memantine® tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state'}, {'id': 'BG001', 'title': 'Akatinol Memantine® First, Then Memantinol', 'description': 'First Intervention Period (3 day):\n\nAkatinol Memantine® tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state\n\n(21 day washout period)\n\nSecond Intervention Period (3 day):\n\nMemantinol tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'two-way crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-13', 'studyFirstSubmitDate': '2017-04-18', 'resultsFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2017-04-19', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-13', 'studyFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of Memantinol by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))', 'timeFrame': '0 hours (pre-dose), as well as at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose', 'description': 'Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf), of memantinol sourced in Memantinol® (JSC "GEROPHARM", Russia) and Akatinol Memantine® (Merz Pharma GmbH \\& Co. KGaA, Germany)'}, {'measure': 'Pharmacokinetics of Memantinol by Assessment of Observed Maximum Plasma Concentration (Cmax)', 'timeFrame': '0 hours (pre-dose), as well as at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose', 'description': 'Comparison of the pharmacokinetic profile in terms of observed maximum plasma concentration, taken directly from the individual concentration-time curve, Cmax, of memantinol sourced in Memantinol® (JSC "GEROPHARM", Russia) and Akatinol Memantine® (Merz Pharma GmbH \\& Co. KGaA, Germany)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bioequivalence, AUC, Cmax, Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma GmbH \\& Co. KGaA, Germany) 20 mg tablets in normal healthy subjects', 'detailedDescription': 'Study to evaluate the bioequivalence of orally administered memantinol preparations, film-coated tablets, 20 mg'}, '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; if the Hormonal contraceptives was used they must canceled have at least 2 month before the study.\n\nfrom the time of IMP administration until 3 months after the last dose of IMP.\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, neuroendocrinal 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.'}, 'identificationModule': {'nctId': 'NCT03121820', 'briefTitle': 'Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Geropharm'}, 'officialTitle': 'A Two-way Crossover, Open-label, Single-dose, Fasting, Bioequivalence Study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg Tablets Versus Akatinol Memantine® (Merz Pharma GmbH & Co. KGaA, Germany) 20 mg Tablets in Normal Healthy Subjects', 'orgStudyIdInfo': {'id': 'BIOMEM-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Memantinol tablets, 20 mg', 'description': 'Treatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC "GEROPHARM", Russia - test)', 'interventionNames': ['Drug: Memantinol tablets, 20 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Akatinol Memantine® tablets, 20 mg', 'description': 'Treatment B: a single oral dose of memantin 20 mg film-coated tablet (Merz Pharma GmbH \\& Co. KGaA, Germany - reference)', 'interventionNames': ['Drug: Akatinol Memantine® tablets, 20 mg']}], 'interventions': [{'name': 'Memantinol tablets, 20 mg', 'type': 'DRUG', 'otherNames': ['memantine'], 'description': 'Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition', 'armGroupLabels': ['Memantinol tablets, 20 mg']}, {'name': 'Akatinol Memantine® tablets, 20 mg', 'type': 'DRUG', 'otherNames': ['memantine'], 'description': 'Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH \\& Co. KGaA, Germany) 20 mg film-coated tablets fasting condition', 'armGroupLabels': ['Akatinol Memantine® tablets, 20 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'City Clinical Hospital № 15 named. O.M.filatova', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Igor Makarenko, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Igor.Makarenko@geropharm.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geropharm', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}