Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-07 @ 7:07 AM
Study NCT ID:
NCT02230995
Status:
COMPLETED
Last Update Posted:
2017-03-09
First Post:
2014-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'C570240', 'term': 'empagliflozin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration up to 13 days after last drug administration, ie., upto 20 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Fed 25mg+1000mg FDC', 'description': 'Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.', 'otherNumAtRisk': 30, 'otherNumAffected': 5, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fed 25mg+1000mg Single', 'description': 'Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.', 'otherNumAtRisk': 30, 'otherNumAffected': 5, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC0-tz of Empagliflozin in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed 25mg+1000mg FDC', 'description': 'Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.'}, {'id': 'OG001', 'title': 'Fed 25mg+1000mg Single', 'description': 'Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '5370', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '5470', 'spread': '16.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.22', 'ciLowerLimit': '96.11', 'ciUpperLimit': '100.39', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.0', 'estimateComment': 'Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \\& fixed effect for 'sequence', 'period' \\& 'treatment'.", 'nonInferiorityComment': 'The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration', 'description': 'Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)', 'unitOfMeasure': 'nmol·h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS set'}, {'type': 'PRIMARY', 'title': 'AUC0-tz of Metformin in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed 25mg+1000mg FDC', 'description': 'Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.'}, {'id': 'OG001', 'title': 'Fed 25mg+1000mg Single', 'description': 'Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '11000', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '10800', 'spread': '22.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.14', 'ciLowerLimit': '98.65', 'ciUpperLimit': '105.76', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.9', 'estimateComment': 'Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \\& fixed effect for 'sequence', 'period' \\& 'treatment'.", 'nonInferiorityComment': 'The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration', 'unitOfMeasure': 'ng·h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Set (PKS): This analysis set included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.'}, {'type': 'PRIMARY', 'title': 'Cmax of Empagliflozin in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed 25mg+1000mg FDC', 'description': 'Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.'}, {'id': 'OG001', 'title': 'Fed 25mg+1000mg Single', 'description': 'Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '590', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '597', 'spread': '19.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.70', 'ciLowerLimit': '93.51', 'ciUpperLimit': '104.17', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.3', 'estimateComment': 'Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \\& fixed effect for 'sequence', 'period' \\& 'treatment'.", 'nonInferiorityComment': 'The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration', 'description': 'Maximum measured concentration of empagliflozin in plasma (Cmax)', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS set'}, {'type': 'PRIMARY', 'title': 'Cmax of Metformin in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed 25mg+1000mg FDC', 'description': 'Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.'}, {'id': 'OG001', 'title': 'Fed 25mg+1000mg Single', 'description': 'Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '1120', 'spread': '23.0', 'groupId': 'OG000'}, {'value': '1060', 'spread': '24.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.69', 'ciLowerLimit': '100.78', 'ciUpperLimit': '110.84', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '10.9', 'estimateComment': 'Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \\& fixed effect for 'sequence', 'period' \\& 'treatment'.", 'nonInferiorityComment': 'The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration', 'description': 'Maximum measured concentration of the metformin in plasma', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS set'}, {'type': 'SECONDARY', 'title': 'AUC0-infinity of Empagliflozin in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed 25mg+1000mg FDC', 'description': 'Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.'}, {'id': 'OG001', 'title': 'Fed 25mg+1000mg Single', 'description': 'Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '5460', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '5550', 'spread': '16.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.32', 'ciLowerLimit': '96.16', 'ciUpperLimit': '100.53', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.1', 'estimateComment': 'Relative bioavailability of empagliflozin was estimated by ratios of adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \\& fixed effect for 'sequence', 'period' \\& 'treatment'."}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration', 'description': 'Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)', 'unitOfMeasure': 'nmol·h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS set'}, {'type': 'SECONDARY', 'title': 'AUC0-infinity of Metformin in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fed 25mg+1000mg FDC', 'description': 'Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.'}, {'id': 'OG001', 'title': 'Fed 25mg+1000mg Single', 'description': 'Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '11500', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '11000', 'spread': '22.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.66', 'ciLowerLimit': '101.36', 'ciUpperLimit': '108.07', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.3', 'estimateComment': 'Relative bioavailability of metformin was estimated by the ratios of the adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \\& fixed effect for 'sequence', 'period' \\& 'treatment'."}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fed 25mg+1000mg FDC/Single', 'description': 'Subjects received in period 1 a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.\n\n2 treatments separated by a wash-out period of at least 7 days.'}, {'id': 'FG001', 'title': 'Fed 25mg+1000mg Single/FDC', 'description': 'Subjects received in period 1 a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.\n\n2 treatments separated by a wash-out period of at least 7 days.'}], 'periods': [{'title': 'Period 1 + Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2 + Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This was an open-label, randomised, 2-way crossover trial with 2 treatments (T and R) and 2 treatment sequences (T\\_R and R\\_T). Trial drug administrations of the 2 single dose treatments were separated by a washout period of at least 7 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fed 25mg+1000mg FDC/Single', 'description': 'Subjects received in period 1 a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.\n\n2 treatments separated by a wash-out period of at least 7 days.'}, {'id': 'BG001', 'title': 'Fed 25mg+1000mg Single/FDC', 'description': 'Subjects received in period 1 a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.\n\n2 treatments separated by a wash-out period of at least 7 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.60', 'spread': '9.30', 'groupId': 'BG000'}, {'value': '32.00', 'spread': '9.80', 'groupId': 'BG001'}, {'value': '34.30', 'spread': '9.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2014-08-29', 'resultsFirstSubmitDate': '2017-01-19', 'studyFirstSubmitQcDate': '2014-08-29', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-19', 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-tz of Empagliflozin in Plasma', 'timeFrame': '-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration', 'description': 'Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)'}, {'measure': 'AUC0-tz of Metformin in Plasma', 'timeFrame': '-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration'}, {'measure': 'Cmax of Empagliflozin in Plasma', 'timeFrame': '-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration', 'description': 'Maximum measured concentration of empagliflozin in plasma (Cmax)'}, {'measure': 'Cmax of Metformin in Plasma', 'timeFrame': '-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration', 'description': 'Maximum measured concentration of the metformin in plasma'}], 'secondaryOutcomes': [{'measure': 'AUC0-infinity of Empagliflozin in Plasma', 'timeFrame': '-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration', 'description': 'Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)'}, {'measure': 'AUC0-infinity of Metformin in Plasma', 'timeFrame': '-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and metformin extended release under fed conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Healthy male and female subjects\n\nExclusion criteria:\n\n\\- Any relevant deviation from healthy condition.'}, 'identificationModule': {'nctId': 'NCT02230995', 'briefTitle': 'Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release (25 mg/1000 mg) Compared With the Free Combination of Empagliflozin and Metformin Extended Release Tablets in Healthy Subjects Following a High-fat, High-caloric Meal (an Open-label, Randomised, Single Dose, Crossover Trial)', 'orgStudyIdInfo': {'id': '1276.15'}, 'secondaryIdInfos': [{'id': '2014-002016-17', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fixed dose combination', 'description': 'Single dose empagliflozin/metformin', 'interventionNames': ['Drug: empagliflozin/metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single tablets combination', 'description': 'single doses empagliflozin and metformin', 'interventionNames': ['Drug: metformin', 'Drug: empagliflozin']}], 'interventions': [{'name': 'metformin', 'type': 'DRUG', 'description': 'single dose of metformin given as tablets', 'armGroupLabels': ['Single tablets combination']}, {'name': 'empagliflozin/metformin', 'type': 'DRUG', 'description': 'Single dose empagliflozin/metformin given as fixed-dose combination tablet', 'armGroupLabels': ['Fixed dose combination']}, {'name': 'empagliflozin', 'type': 'DRUG', 'description': 'single dose of empagliflozin given as tablet', 'armGroupLabels': ['Single tablets combination']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Biberach an der Riss', 'country': 'Germany', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.09345, 'lon': 9.79053}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}