Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT02102932
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2014-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}, {'id': 'D008687', 'term': 'Metformin'}], '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': '800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'phoneExt': '+1', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "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': 'First drug administration until 7 days after last drug administration, up to 8 days', 'eventGroups': [{'id': 'EG000', 'title': 'T1 (FDC)', 'description': 'Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin', 'otherNumAtRisk': 24, 'otherNumAffected': 8, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'R1 (FC)', 'description': 'Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg', 'otherNumAtRisk': 24, 'otherNumAffected': 8, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'T2 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin', 'otherNumAtRisk': 24, 'otherNumAffected': 9, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'R2 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg', 'otherNumAtRisk': 24, 'otherNumAffected': 11, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'T3 (FDC)', 'description': 'Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin', 'otherNumAtRisk': 24, 'otherNumAffected': 12, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'R3 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg', 'otherNumAtRisk': 24, 'otherNumAffected': 11, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'T4 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin', 'otherNumAtRisk': 24, 'otherNumAffected': 7, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'R4 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg', 'otherNumAtRisk': 24, 'otherNumAffected': 9, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood bilirubin unconjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC(0-∞) for Empagliflozin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'T1 (FDC)', 'description': 'Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin'}, {'id': 'OG001', 'title': 'R1 (FC)', 'description': 'Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg'}, {'id': 'OG002', 'title': 'T2 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin'}, {'id': 'OG003', 'title': 'R2 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg'}, {'id': 'OG004', 'title': 'T3 (FDC)', 'description': 'Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin'}, {'id': 'OG005', 'title': 'R3 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg'}, {'id': 'OG006', 'title': 'T4 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin'}, {'id': 'OG007', 'title': 'R4 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4330', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '4110', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '1680', 'spread': '22.0', 'groupId': 'OG002'}, {'value': '1630', 'spread': '21.1', 'groupId': 'OG003'}, {'value': '4200', 'spread': '20.3', 'groupId': 'OG004'}, {'value': '4060', 'spread': '18.6', 'groupId': 'OG005'}, {'value': '1610', 'spread': '16.5', 'groupId': 'OG006'}, {'value': '1560', 'spread': '17.7', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.29', 'ciLowerLimit': '101.92', 'ciUpperLimit': '108.78', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.6', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0000', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.23', 'ciLowerLimit': '99.91', 'ciUpperLimit': '106.65', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.6', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0000', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.56', 'ciLowerLimit': '99.73', 'ciUpperLimit': '107.54', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.6', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0000', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.81', 'ciLowerLimit': '99.36', 'ciUpperLimit': '106.37', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.9', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration', 'description': 'Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 extrapolated to infinity', 'unitOfMeasure': 'nmol * h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS):\n\nThe PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK.'}, {'type': 'PRIMARY', 'title': 'AUC(0-∞) for Metformin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'T1 (FDC)', 'description': 'Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin'}, {'id': 'OG001', 'title': 'R1 (FC)', 'description': 'Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg'}, {'id': 'OG002', 'title': 'T2 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin'}, {'id': 'OG003', 'title': 'R2 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg'}, {'id': 'OG004', 'title': 'T3 (FDC)', 'description': 'Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin'}, {'id': 'OG005', 'title': 'R3 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg'}, {'id': 'OG006', 'title': 'T4 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin'}, {'id': 'OG007', 'title': 'R4 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '11600', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '11100', 'spread': '17.4', 'groupId': 'OG001'}, {'value': '11700', 'spread': '21.8', 'groupId': 'OG002'}, {'value': '11000', 'spread': '24.0', 'groupId': 'OG003'}, {'value': '7800', 'spread': '18.9', 'groupId': 'OG004'}, {'value': '7510', 'spread': '17.8', 'groupId': 'OG005'}, {'value': '7030', 'spread': '20.7', 'groupId': 'OG006'}, {'value': '7340', 'spread': '18.8', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.56', 'ciLowerLimit': '97.56', 'ciUpperLimit': '112.07', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '14.0', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.80', 'ciLowerLimit': '99.32', 'ciUpperLimit': '112.70', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.8', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0000', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.75', 'ciLowerLimit': '98.18', 'ciUpperLimit': '109.63', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '11.2', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0000', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.77', 'ciLowerLimit': '89.88', 'ciUpperLimit': '102.03', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '12.8', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration', 'description': 'Area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity', 'unitOfMeasure': 'ng * h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS):\n\nThe PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK.'}, {'type': 'PRIMARY', 'title': 'Cmax for Empagliflozin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'T1 (FDC)', 'description': 'Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin'}, {'id': 'OG001', 'title': 'R1 (FC)', 'description': 'Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg'}, {'id': 'OG002', 'title': 'T2 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin'}, {'id': 'OG003', 'title': 'R2 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg'}, {'id': 'OG004', 'title': 'T3 (FDC)', 'description': 'Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin'}, {'id': 'OG005', 'title': 'R3 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg'}, {'id': 'OG006', 'title': 'T4 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin'}, {'id': 'OG007', 'title': 'R4 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '644', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '605', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '263', 'spread': '17.7', 'groupId': 'OG002'}, {'value': '237', 'spread': '20.7', 'groupId': 'OG003'}, {'value': '569', 'spread': '22.1', 'groupId': 'OG004'}, {'value': '561', 'spread': '25.3', 'groupId': 'OG005'}, {'value': '228', 'spread': '16.4', 'groupId': 'OG006'}, {'value': '221', 'spread': '22.2', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.44', 'ciLowerLimit': '100.44', 'ciUpperLimit': '112.80', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '11.8', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0021', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '110.78', 'ciLowerLimit': '103.80', 'ciUpperLimit': '118.24', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '13.2', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0000', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.38', 'ciLowerLimit': '94.82', 'ciUpperLimit': '108.39', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '13.6', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.02', 'ciLowerLimit': '95.08', 'ciUpperLimit': '111.63', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '16.3', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration', 'description': 'Maximum measured concentration of the empagliflozin in plasma', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS):\n\nThe PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK.'}, {'type': 'PRIMARY', 'title': 'Cmax for Metformin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'T1 (FDC)', 'description': 'Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin'}, {'id': 'OG001', 'title': 'R1 (FC)', 'description': 'Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg'}, {'id': 'OG002', 'title': 'T2 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin'}, {'id': 'OG003', 'title': 'R2 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg'}, {'id': 'OG004', 'title': 'T3 (FDC)', 'description': 'Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin'}, {'id': 'OG005', 'title': 'R3 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg'}, {'id': 'OG006', 'title': 'T4 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin'}, {'id': 'OG007', 'title': 'R4 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '1920', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '1830', 'spread': '16.6', 'groupId': 'OG001'}, {'value': '1950', 'spread': '26.4', 'groupId': 'OG002'}, {'value': '1840', 'spread': '26.0', 'groupId': 'OG003'}, {'value': '1290', 'spread': '22.2', 'groupId': 'OG004'}, {'value': '1230', 'spread': '27.1', 'groupId': 'OG005'}, {'value': '1150', 'spread': '25.5', 'groupId': 'OG006'}, {'value': '1190', 'spread': '21.3', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.91', 'ciLowerLimit': '99.29', 'ciUpperLimit': '110.86', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '11.2', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0008', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.32', 'ciLowerLimit': '98.39', 'ciUpperLimit': '114.88', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '15.7', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0003', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.44', 'ciLowerLimit': '96.68', 'ciUpperLimit': '112.82', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '15.7', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.61', 'ciLowerLimit': '88.90', 'ciUpperLimit': '104.99', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '16.9', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration', 'description': 'Maximum measured concentration of the metformin in plasma', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS):\n\nThe PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK.'}, {'type': 'SECONDARY', 'title': 'AUC(0-tz) of Empagliflozin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'T1 (FDC)', 'description': 'Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin'}, {'id': 'OG001', 'title': 'R1 (FC)', 'description': 'Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg'}, {'id': 'OG002', 'title': 'T2 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin'}, {'id': 'OG003', 'title': 'R2 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg'}, {'id': 'OG004', 'title': 'T3 (FDC)', 'description': 'Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin'}, {'id': 'OG005', 'title': 'R3 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg'}, {'id': 'OG006', 'title': 'T4 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin'}, {'id': 'OG007', 'title': 'R4 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4270', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '4060', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '1650', 'spread': '21.5', 'groupId': 'OG002'}, {'value': '1600', 'spread': '21.0', 'groupId': 'OG003'}, {'value': '4140', 'spread': '19.7', 'groupId': 'OG004'}, {'value': '4010', 'spread': '18.5', 'groupId': 'OG005'}, {'value': '1580', 'spread': '16.7', 'groupId': 'OG006'}, {'value': '1540', 'spread': '17.7', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.16', 'ciLowerLimit': '101.97', 'ciUpperLimit': '108.45', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.2', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0000', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.07', 'ciLowerLimit': '99.75', 'ciUpperLimit': '106.50', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.6', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0000', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.14', 'ciLowerLimit': '99.37', 'ciUpperLimit': '107.04', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.5', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0000', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.61', 'ciLowerLimit': '99.10', 'ciUpperLimit': '106.25', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.0', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration', 'description': 'Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 up to the last quantifiable data point', 'unitOfMeasure': 'nmol * h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS):\n\nThe PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK.'}, {'type': 'SECONDARY', 'title': 'AUC(0-tz) of Metformin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '24', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'T1 (FDC)', 'description': 'Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin'}, {'id': 'OG001', 'title': 'R1 (FC)', 'description': 'Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg'}, {'id': 'OG002', 'title': 'T2 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin'}, {'id': 'OG003', 'title': 'R2 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg'}, {'id': 'OG004', 'title': 'T3 (FDC)', 'description': 'Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin'}, {'id': 'OG005', 'title': 'R3 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg'}, {'id': 'OG006', 'title': 'T4 (FDC)', 'description': 'Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin'}, {'id': 'OG007', 'title': 'R4 (FC)', 'description': 'Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '11400', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '10800', 'spread': '17.6', 'groupId': 'OG001'}, {'value': '11400', 'spread': '23.1', 'groupId': 'OG002'}, {'value': '10800', 'spread': '25.1', 'groupId': 'OG003'}, {'value': '7630', 'spread': '18.9', 'groupId': 'OG004'}, {'value': '7420', 'spread': '17.9', 'groupId': 'OG005'}, {'value': '6790', 'spread': '24.7', 'groupId': 'OG006'}, {'value': '7230', 'spread': '18.3', 'groupId': 'OG007'}]}]}], 'analyses': [{'pValue': '0.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.33', 'ciLowerLimit': '99.34', 'ciUpperLimit': '111.68', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '11.9', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.75', 'ciLowerLimit': '99.09', 'ciUpperLimit': '112.85', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '13.2', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0000', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.90', 'ciLowerLimit': '97.11', 'ciUpperLimit': '109.03', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '11.7', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG006', 'OG007'], 'paramType': 'Ratio of the geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '93.84', 'ciLowerLimit': '87.74', 'ciUpperLimit': '100.36', 'pValueComment': 'P-value for ratio outside interval 80-125', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '13.6', 'estimateComment': 'Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.', 'groupDescription': "The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:\n\n'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.", 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration', 'description': 'Area under the concentration-time curve of the metformin in plasma over the time interval from 0 up to the last quantifiable data point', 'unitOfMeasure': 'ng* h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS):\n\nThe PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T1R1', 'description': 'Study Part 1:\n\nT1: Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T1 and R1.'}, {'id': 'FG001', 'title': 'R1T1', 'description': 'Study Part 1:\n\nR1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg T1: Oral administration of a single FDC tablet 12.5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R1 and T1.'}, {'id': 'FG002', 'title': 'T2R2', 'description': 'Study Part 2:\n\nT2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T2 and R2.'}, {'id': 'FG003', 'title': 'R2T2', 'description': 'Study part 2:\n\nR2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R2 and T2.'}, {'id': 'FG004', 'title': 'T3R3', 'description': 'Study Part 3:\n\nT3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T3 and R3.'}, {'id': 'FG005', 'title': 'R3T3', 'description': 'Study Part 3:\n\nR3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R3 and T3'}, {'id': 'FG006', 'title': 'T4R4', 'description': 'Study Part 4:\n\nT4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T4 and R4.'}, {'id': 'FG007', 'title': 'R4T4', 'description': 'Study Part 4:\n\nR4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R4 and T4'}], 'periods': [{'title': 'Overall Study', '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'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '12'}]}, {'type': 'COMPLETED', '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'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', '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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was performed as an open-label, randomised, single-dose, two-way crossover trial consisting of four trial parts. In each trial part the aim was to investigate the relative bioavailability of the Test treatment (T) and to compare it with the Reference treatment (R).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '96', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'T1R1', 'description': 'Study Part 1:\n\nT1: Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T1 and R1.'}, {'id': 'BG001', 'title': 'R1T1', 'description': 'Study Part 1:\n\nR1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg T1: Oral administration of a single FDC tablet 12.5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R1 and T1.'}, {'id': 'BG002', 'title': 'T2R2', 'description': 'Study Part 2:\n\nT2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T2 and R2.'}, {'id': 'BG003', 'title': 'R2T2', 'description': 'Study part 2:\n\nR2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R2 and T2.'}, {'id': 'BG004', 'title': 'T3R3', 'description': 'Study Part 3:\n\nT3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T3 and R3.'}, {'id': 'BG005', 'title': 'R3T3', 'description': 'Study Part 3:\n\nR3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R3 and T3'}, {'id': 'BG006', 'title': 'T4R4', 'description': 'Study Part 4:\n\nT4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T4 and R4.'}, {'id': 'BG007', 'title': 'R4T4', 'description': 'Study Part 4:\n\nR4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R4 and T4'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.9', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '27.0', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '26.8', 'spread': '5.3', 'groupId': 'BG002'}, {'value': '24.3', 'spread': '3.4', 'groupId': 'BG003'}, {'value': '24.8', 'spread': '4.3', 'groupId': 'BG004'}, {'value': '24.4', 'spread': '3.9', 'groupId': 'BG005'}, {'value': '24.6', 'spread': '3.7', 'groupId': 'BG006'}, {'value': '25.6', 'spread': '4.8', 'groupId': 'BG007'}, {'value': '25.5', 'spread': '4.5', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '48', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '48', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS): The TS included all subjects who were dispensed study medication and were documented to have received at least 1 dose of trial medication'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-21', 'studyFirstSubmitDate': '2014-03-31', 'resultsFirstSubmitDate': '2015-08-21', 'studyFirstSubmitQcDate': '2014-03-31', 'lastUpdatePostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-21', 'studyFirstPostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC(0-∞) for Empagliflozin', 'timeFrame': '1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration', 'description': 'Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 extrapolated to infinity'}, {'measure': 'AUC(0-∞) for Metformin', 'timeFrame': '1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration', 'description': 'Area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity'}, {'measure': 'Cmax for Empagliflozin', 'timeFrame': '1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration', 'description': 'Maximum measured concentration of the empagliflozin in plasma'}, {'measure': 'Cmax for Metformin', 'timeFrame': '1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration', 'description': 'Maximum measured concentration of the metformin in plasma'}], 'secondaryOutcomes': [{'measure': 'AUC(0-tz) of Empagliflozin', 'timeFrame': '1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration', 'description': 'Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 up to the last quantifiable data point'}, {'measure': 'AUC(0-tz) of Metformin', 'timeFrame': '1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration', 'description': 'Area under the concentration-time curve of the metformin in plasma over the time interval from 0 up to the last quantifiable data point'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of Empagliflozin and metformin compared to the administration of single tablets (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patient's compliance with antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nHealthy male and female subjects\n\nExclusion criteria:\n\nAny relevant deviation from healthy conditions'}, 'identificationModule': {'nctId': 'NCT02102932', 'briefTitle': 'Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Relative Bioavailability of Empagliflozin (12.5 or 5 mg)/Metformin (850 mg or 500 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together to Healthy Chinese Male and Female Volunteers in an Open-label, Randomised, Single-dose, Two-way Crossover Study', 'orgStudyIdInfo': {'id': '1276.23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '12.5 mg empagliflozin/850 mg metformin', 'description': '24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/850 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 850 mg metformin tablets single dose in randomized order', 'interventionNames': ['Drug: 12.5 mg empagliflozin', 'Drug: 850 mg metformin', 'Drug: 12.5 mg empagliflozin/850 mg metformin FDC']}, {'type': 'EXPERIMENTAL', 'label': '5 mg empagliflozin/850 mg metformin', 'description': '24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/850 mg metformin and single Empagliflozin(5mg) and metformin (850mg) tablets single dose in randomized order', 'interventionNames': ['Drug: 5 mg empagliflozin/850 mg metformin FDC', 'Drug: 5 mg empagliflozin', 'Drug: 850 mg metformin']}, {'type': 'EXPERIMENTAL', 'label': '12.5 mg empagliflozin/500 mg metformin', 'description': '24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/500 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 500 mg metformin tablets single dose in randomized order', 'interventionNames': ['Drug: 12.5 mg empagliflozin', 'Drug: 12.5 mg empagliflozin/500 mg metformin FDC', 'Drug: 500 mg metformin']}, {'type': 'EXPERIMENTAL', 'label': '5 mg empagliflozin/500 mg metformin', 'description': '24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/500 mg metformin and single Empagliflozin(5mg) and metformin (500mg) tablets single dose in randomized order', 'interventionNames': ['Drug: 5 mg empagliflozin', 'Drug: 5 mg empagliflozin/500 mg metformin FDC', 'Drug: 500 mg metformin']}], 'interventions': [{'name': '5 mg empagliflozin/850 mg metformin FDC', 'type': 'DRUG', 'description': '5 mg empagliflozin/850 mg metformin FDC', 'armGroupLabels': ['5 mg empagliflozin/850 mg metformin']}, {'name': '12.5 mg empagliflozin', 'type': 'DRUG', 'description': '10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet', 'armGroupLabels': ['12.5 mg empagliflozin/500 mg metformin']}, {'name': '12.5 mg empagliflozin', 'type': 'DRUG', 'description': '10mg empagliflozin tablet and 2.5 mg empagliflozin tablet', 'armGroupLabels': ['12.5 mg empagliflozin/850 mg metformin']}, {'name': '850 mg metformin', 'type': 'DRUG', 'description': '850mg metformin tablet', 'armGroupLabels': ['12.5 mg empagliflozin/850 mg metformin']}, {'name': '5 mg empagliflozin', 'type': 'DRUG', 'description': '5 mg empagliflozin', 'armGroupLabels': ['5 mg empagliflozin/850 mg metformin']}, {'name': '5 mg empagliflozin', 'type': 'DRUG', 'description': '5 mg empagliflozin', 'armGroupLabels': ['5 mg empagliflozin/500 mg metformin']}, {'name': '850 mg metformin', 'type': 'DRUG', 'description': '850 mg metformin', 'armGroupLabels': ['5 mg empagliflozin/850 mg metformin']}, {'name': '12.5 mg empagliflozin/850 mg metformin FDC', 'type': 'DRUG', 'description': '12.5 mg empagliflozin/850 mg metformin FDC', 'armGroupLabels': ['12.5 mg empagliflozin/850 mg metformin']}, {'name': '12.5 mg empagliflozin/500 mg metformin FDC', 'type': 'DRUG', 'description': '12.5 mg empagliflozin/500 mg metformin FDC', 'armGroupLabels': ['12.5 mg empagliflozin/500 mg metformin']}, {'name': '5 mg empagliflozin/500 mg metformin FDC', 'type': 'DRUG', 'description': '5 mg empagliflozin/500 mg metformin FDC', 'armGroupLabels': ['5 mg empagliflozin/500 mg metformin']}, {'name': '500 mg metformin', 'type': 'DRUG', 'description': '500 mg metformin', 'armGroupLabels': ['12.5 mg empagliflozin/500 mg metformin']}, {'name': '500 mg metformin', 'type': 'DRUG', 'description': '500 mg metformin', 'armGroupLabels': ['5 mg empagliflozin/500 mg metformin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': '1276.23.86002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], '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'}}}}