Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT01975220
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2013-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first trial medication intake until next intake or the end-of-trial visit, 10 days', 'eventGroups': [{'id': 'EG000', 'title': 'High Dose, Fasted: 1 FDC Tablet', 'description': '1 fixed dose combination (FDC) tablet under fasted conditions:\n\n25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR, FDC tablet', 'otherNumAtRisk': 23, 'otherNumAffected': 4, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Dose, Fasted: 3 Single Tablets', 'description': '3 single tablets under fasted conditions:\n\n1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets', 'otherNumAtRisk': 23, 'otherNumAffected': 1, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High Dose, Fed: 1 FDC Tablet', 'description': '1 fixed dose combination (FDC) tablet under fed conditions:\n\n25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet', 'otherNumAtRisk': 24, 'otherNumAffected': 1, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'High Dose, Fed: 3 Single Tablets', 'description': '3 single tablets under fed conditions:\n\n1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets', 'otherNumAtRisk': 24, 'otherNumAffected': 2, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Low Dose, Fasted: 2 FDC Tablets', 'description': '2 fixed dose combination (FDC) tablets under fasted conditions:\n\n12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets', 'otherNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Low Dose, Fasted: 4 Single Tablets', 'description': '4 single tablets under fed conditions:\n\n1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets', 'otherNumAtRisk': 24, 'otherNumAffected': 1, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose, Fasted: 1 FDC Tablet', 'description': '1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)'}, {'id': 'OG001', 'title': 'High Dose, Fasted: 3 Single Tablets', 'description': '3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR'}, {'id': 'OG002', 'title': 'High Dose, Fed: 1 FDC Tablet', 'description': '1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR'}, {'id': 'OG003', 'title': 'High Dose, Fed: 3 Single Tablets', 'description': '3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR'}, {'id': 'OG004', 'title': 'Low Dose, Fasted: 2 FDC Tablets', 'description': '2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR'}, {'id': 'OG005', 'title': 'Low Dose, Fasted: 4 Single Tablets', 'description': '4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR'}], 'classes': [{'categories': [{'measurements': [{'value': '6430', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '6430', 'spread': '21.7', 'groupId': 'OG001'}, {'value': '5690', 'spread': '21.0', 'groupId': 'OG002'}, {'value': '5850', 'spread': '19.6', 'groupId': 'OG003'}, {'value': '7160', 'spread': '19.5', 'groupId': 'OG004'}, {'value': '7110', 'spread': '20.5', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.98', 'ciLowerLimit': '97.275', 'ciUpperLimit': '102.751', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.4', 'estimateComment': "Adjusted geometric mean (GM) ratio(%) was calculated as GM of 'High dose, fasted:1 FDC tablet' divided by GM of 'High dose, fasted:3 single tablets'.The 'standard deviation' is actually intra-individual geometric coefficient of variation (gCV (%)).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.09', 'ciLowerLimit': '93.857', 'ciUpperLimit': '100.436', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.7', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.\n\nThe 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.70', 'ciLowerLimit': '98.28', 'ciUpperLimit': '103.18', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.9', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.\n\nThe 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration', 'description': 'Area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Empagliflozin', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS): This set includes all subjects of the Treated set (TS) who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of Pharmacokinetic (PK) endpoints.'}, {'type': 'PRIMARY', 'title': 'AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose, Fasted: 1 FDC Tablet', 'description': '1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)'}, {'id': 'OG001', 'title': 'High Dose, Fasted: 3 Single Tablets', 'description': '3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR'}, {'id': 'OG002', 'title': 'High Dose, Fed: 1 FDC Tablet', 'description': '1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR'}, {'id': 'OG003', 'title': 'High Dose, Fed: 3 Single Tablets', 'description': '3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR'}, {'id': 'OG004', 'title': 'Low Dose, Fasted: 2 FDC Tablets', 'description': '2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR'}, {'id': 'OG005', 'title': 'Low Dose, Fasted: 4 Single Tablets', 'description': '4 single tablets, low dose, fasted: 1 x 25 mg tablets Empagliflozin / 3 x 500 mg tablets Metformin XR'}], 'classes': [{'categories': [{'measurements': [{'value': '6350', 'spread': '32.8', 'groupId': 'OG000'}, {'value': '6700', 'spread': '28.9', 'groupId': 'OG001'}, {'value': '13000', 'spread': '23.6', 'groupId': 'OG002'}, {'value': '13100', 'spread': '21.1', 'groupId': 'OG003'}, {'value': '10200', 'spread': '38.5', 'groupId': 'OG004'}, {'value': '10300', 'spread': '38.3', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0256', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.65', 'ciLowerLimit': '82.29', 'ciUpperLimit': '108.88', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '28.1', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.69', 'ciLowerLimit': '96.25', 'ciUpperLimit': '103.26', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.1', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.\n\nThe 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing'}, {'pValue': '0.0020', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.76', 'ciLowerLimit': '88.65', 'ciUpperLimit': '112.27', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '24.2', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.\n\nThe 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration', 'description': 'AUC 0-tz (area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point); Metformin', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.'}, {'type': 'SECONDARY', 'title': 'AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose, Fasted: 1 FDC Tablet', 'description': '1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)'}, {'id': 'OG001', 'title': 'High Dose, Fasted: 3 Single Tablets', 'description': '3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR'}, {'id': 'OG002', 'title': 'High Dose, Fed: 1 FDC Tablet', 'description': '1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR'}, {'id': 'OG003', 'title': 'High Dose, Fed: 3 Single Tablets', 'description': '3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR'}, {'id': 'OG004', 'title': 'Low Dose, Fasted: 2 FDC Tablets', 'description': '2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR'}, {'id': 'OG005', 'title': 'Low Dose, Fasted: 4 Single Tablets', 'description': '4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR'}], 'classes': [{'categories': [{'measurements': [{'value': '6510', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '6490', 'spread': '21.6', 'groupId': 'OG001'}, {'value': '5800', 'spread': '21.8', 'groupId': 'OG002'}, {'value': '5970', 'spread': '20.5', 'groupId': 'OG003'}, {'value': '7240', 'spread': '19.7', 'groupId': 'OG004'}, {'value': '7180', 'spread': '20.8', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.10', 'ciLowerLimit': '97.555', 'ciUpperLimit': '102.719', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.1', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing.'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.01', 'ciLowerLimit': '93.622', 'ciUpperLimit': '100.531', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.0', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.\n\nThe 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing.'}, {'pValue': '<0.0001', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.78', 'ciLowerLimit': '98.36', 'ciUpperLimit': '103.27', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.9', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.\n\nThe 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration', 'description': 'AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Empagliflozin', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.'}, {'type': 'PRIMARY', 'title': 'Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose, Fasted: 1 FDC Tablet', 'description': '1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)'}, {'id': 'OG001', 'title': 'High Dose, Fasted: 3 Single Tablets', 'description': '3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR'}, {'id': 'OG002', 'title': 'High Dose, Fed: 1 FDC Tablet', 'description': '1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR'}, {'id': 'OG003', 'title': 'High Dose, Fed: 3 Single Tablets', 'description': '3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR'}, {'id': 'OG004', 'title': 'Low Dose, Fasted: 2 FDC Tablets', 'description': '2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR'}, {'id': 'OG005', 'title': 'Low Dose, Fasted: 4 Single Tablets', 'description': '4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR'}], 'classes': [{'categories': [{'measurements': [{'value': '886', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '810', 'spread': '28.1', 'groupId': 'OG001'}, {'value': '559', 'spread': '29.0', 'groupId': 'OG002'}, {'value': '601', 'spread': '25.0', 'groupId': 'OG003'}, {'value': '1010', 'spread': '27.0', 'groupId': 'OG004'}, {'value': '963', 'spread': '29.7', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '109.07', 'ciLowerLimit': '99.892', 'ciUpperLimit': '119.100', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '17.4', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing'}, {'pValue': '0.0004', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.42', 'ciLowerLimit': '86.781', 'ciUpperLimit': '98.428', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.5', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.\n\nThe 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing'}, {'pValue': '0.0014', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.37', 'ciLowerLimit': '96.600', 'ciUpperLimit': '114.942', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '17.7', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.\n\nThe 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration', 'description': 'Cmax (maximum measured concentration of the analyte in plasma); Empagliflozin', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.'}, {'type': 'PRIMARY', 'title': 'Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose, Fasted: 1 FDC Tablet', 'description': '1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)'}, {'id': 'OG001', 'title': 'High Dose, Fasted: 3 Single Tablets', 'description': '3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR'}, {'id': 'OG002', 'title': 'High Dose, Fed: 1 FDC Tablet', 'description': '1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR'}, {'id': 'OG003', 'title': 'High Dose, Fed: 3 Single Tablets', 'description': '3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR'}, {'id': 'OG004', 'title': 'Low Dose, Fasted: 2 FDC Tablets', 'description': '2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR'}, {'id': 'OG005', 'title': 'Low Dose, Fasted: 4 Single Tablets', 'description': '4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR'}], 'classes': [{'categories': [{'measurements': [{'value': '822', 'spread': '37.4', 'groupId': 'OG000'}, {'value': '851', 'spread': '28.8', 'groupId': 'OG001'}, {'value': '1180', 'spread': '27.4', 'groupId': 'OG002'}, {'value': '1070', 'spread': '22.8', 'groupId': 'OG003'}, {'value': '1300', 'spread': '34.4', 'groupId': 'OG004'}, {'value': '1330', 'spread': '41.3', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0198', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.65', 'ciLowerLimit': '83.337', 'ciUpperLimit': '112.079', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '29.8', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing.'}, {'pValue': '0.0007', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '110.17', 'ciLowerLimit': '103.809', 'ciUpperLimit': '116.926', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.0', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.\n\nThe 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing.'}, {'pValue': '0.0037', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.68', 'ciLowerLimit': '86.942', 'ciUpperLimit': '109.734', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '23.8', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.\n\nThe 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration', 'description': 'Cmax (maximum measured concentration of the analyte in plasma); Metformin', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.'}, {'type': 'SECONDARY', 'title': 'AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose, Fasted: 1 FDC Tablet', 'description': '1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)'}, {'id': 'OG001', 'title': 'High Dose, Fasted: 3 Single Tablets', 'description': '3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR'}, {'id': 'OG002', 'title': 'High Dose, Fed: 1 FDC Tablet', 'description': '1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR'}, {'id': 'OG003', 'title': 'High Dose, Fed: 3 Single Tablets', 'description': '3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR'}, {'id': 'OG004', 'title': 'Low Dose, Fasted: 2 FDC Tablets', 'description': '2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR'}, {'id': 'OG005', 'title': 'Low Dose, Fasted: 4 Single Tablets', 'description': '4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR'}], 'classes': [{'categories': [{'measurements': [{'value': '6490', 'spread': '35.2', 'groupId': 'OG000'}, {'value': '6790', 'spread': '29.6', 'groupId': 'OG001'}, {'value': '13200', 'spread': '24.0', 'groupId': 'OG002'}, {'value': '13200', 'spread': '21.6', 'groupId': 'OG003'}, {'value': '10500', 'spread': '41.9', 'groupId': 'OG004'}, {'value': '10400', 'spread': '39.9', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0254', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.40', 'ciLowerLimit': '82.42', 'ciUpperLimit': '110.44', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '29.4', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing.'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.63', 'ciLowerLimit': '96.21', 'ciUpperLimit': '103.17', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.1', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.\n\nThe 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing.'}, {'pValue': '0.0029', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.06', 'ciLowerLimit': '89.70', 'ciUpperLimit': '113.86', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '24.4', 'estimateComment': "The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.\n\nThe 'standard deviation' is actually the intra-individual gCV (%).", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No formal testing.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration', 'description': 'AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Metformin', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Dose, Fasted: 1 FDC Tablet First, Then 3 Single Tablets', 'description': '1 fixed dose combination (FDC) tablet first, then 3 single tablets under fasted conditions:\n\n25 mg Empagliflozin/1000 mg Metformin extended release (XR), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;\n\n1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets'}, {'id': 'FG001', 'title': 'High Dose, Fasted: 3 Single Tablets First, Then 1 FDC Tablet', 'description': '3 single tablets first, then 1 fixed dose combination (FDC) tablet under fasted conditions:\n\n1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;\n\n25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet'}, {'id': 'FG002', 'title': 'High Dose, Fed: 1 FDC Tablet First, Then 3 Single Tablets', 'description': '1 fixed dose combination (FDC) tablet first, then 3 single tablets under fed conditions:\n\n25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;\n\n1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets'}, {'id': 'FG003', 'title': 'High Dose, Fed: 3 Single Tablets First, Then 1 FDC Tablet', 'description': '3 single tablets first, then 1 fixed dose combination (FDC) tablet under fed conditions:\n\n1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;\n\n25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet'}, {'id': 'FG004', 'title': 'Low Dose, Fasted: 2 FDC Tablets First, Then 4 Single Tablets', 'description': '2 fixed low dose combination (FDC) tablets first, then 4 single tablets under fasted conditions:\n\n12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets;\n\n1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets'}, {'id': 'FG005', 'title': 'Low Dose, Fasted: 4 Single Tablets First, Then 2 FDC Tablets', 'description': '4 single tablets first, then 2 fixed low dose combination (FDC) tablets under fasted conditions:\n\n1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets;\n\n12.5 mg Empagliflozin/750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets'}], 'periods': [{'title': 'Test Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Test Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'High Dose, Fasted', 'description': '1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions:\n\n25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;\n\n1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets'}, {'id': 'BG001', 'title': 'High Dose, Fed', 'description': '1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions:\n\n25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;\n\n1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets'}, {'id': 'BG002', 'title': 'Low Dose, Fasted', 'description': '2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fasted conditions:\n\n12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets;\n\n1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '34.2', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '30.8', 'spread': '8.4', 'groupId': 'BG002'}, {'value': '32.5', 'spread': '8.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set (TS): This patient set includes all subjects who were dispensed study medication and were documented to have taken at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-18', 'studyFirstSubmitDate': '2013-10-29', 'resultsFirstSubmitDate': '2017-01-18', 'studyFirstSubmitQcDate': '2013-10-29', 'lastUpdatePostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-18', 'studyFirstPostDateStruct': {'date': '2013-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration', 'description': 'Area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Empagliflozin'}, {'measure': 'AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration', 'description': 'AUC 0-tz (area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point); Metformin'}, {'measure': 'Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration', 'description': 'Cmax (maximum measured concentration of the analyte in plasma); Empagliflozin'}, {'measure': 'Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration', 'description': 'Cmax (maximum measured concentration of the analyte in plasma); Metformin'}], 'secondaryOutcomes': [{'measure': 'AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration', 'description': 'AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Empagliflozin'}, {'measure': 'AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration', 'description': 'AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Metformin'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin \\& metformin and the single tablets of empagliflozin and metformin when administered singularly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Healthy males or females\n2. Age 18-50 years (incl)\n3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl)\n4. Subjects must be able to understand and comply with study requirements\n\nExclusion criteria:\n\nAny deviation from healthy condition'}, 'identificationModule': {'nctId': 'NCT01975220', 'briefTitle': 'Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Relative Bioavailability of Two Newly Developed FDC Tablet Strengths (25mg/1000mg and 12.5mg/750mg) of Empagliflozin/Metformin Extended Release Compared With the Free Combination of Empagliflozin and Metformin Extended Release in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Study)', 'orgStudyIdInfo': {'id': '1276.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High dose, fasted', 'description': '1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions', 'interventionNames': ['Drug: 25 mg Empagliflozin/1000 mg Metformin XR, FDC', 'Drug: 1 tablet Empagliflozin/2 tablets Metformin XR']}, {'type': 'EXPERIMENTAL', 'label': 'High dose, fed', 'description': '1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions', 'interventionNames': ['Drug: Empagliflozin/Metformin XR, FDC', 'Drug: 1 tablet Empagliflozin/2 tablets Metformin XR']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose, fasted', 'description': '2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fed conditions', 'interventionNames': ['Drug: Empagliflozin/Metformin XR FDC', 'Drug: 1 tablet Empagliflozin/3 tablets Metformin XR']}], 'interventions': [{'name': 'Empagliflozin/Metformin XR, FDC', 'type': 'DRUG', 'description': 'Experimental: high dose empagliflozin/metformin XR, FDC tablet', 'armGroupLabels': ['High dose, fed']}, {'name': 'Empagliflozin/Metformin XR FDC', 'type': 'DRUG', 'description': 'Experimental: low dose empagliflozin/metformin XR, FDC tablet', 'armGroupLabels': ['Low dose, fasted']}, {'name': '25 mg Empagliflozin/1000 mg Metformin XR, FDC', 'type': 'DRUG', 'description': 'Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet', 'armGroupLabels': ['High dose, fasted']}, {'name': '1 tablet Empagliflozin/2 tablets Metformin XR', 'type': 'DRUG', 'description': 'Active Comparator: 1x empagliflozin/2x metformin XR tablets', 'armGroupLabels': ['High dose, fasted']}, {'name': '1 tablet Empagliflozin/3 tablets Metformin XR', 'type': 'DRUG', 'description': 'Active Comparator: 1x empagliflozin/3x metformin XR tablets', 'armGroupLabels': ['Low dose, fasted']}, {'name': '1 tablet Empagliflozin/2 tablets Metformin XR', 'type': 'DRUG', 'description': 'Active Comparator: 1x empagliflozin/2x metformin XR tablets', 'armGroupLabels': ['High dose, fed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': '1276.13.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], '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'}}}}