Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-09 @ 8:18 AM
Study NCT ID:
NCT02084056
Status:
COMPLETED
Last Update Posted:
2016-08-04
First Post:
2014-03-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069476', 'term': 'Linagliptin'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the first drug administration for at least 7 days after the last drug administration, up to 47 days.', 'eventGroups': [{'id': 'EG000', 'title': 'L+M 2000 Fasted', 'description': '5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.', 'otherNumAtRisk': 56, 'otherNumAffected': 20, 'seriousNumAtRisk': 56, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'FDC 2000 Fasted', 'description': '5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.', 'otherNumAtRisk': 58, 'otherNumAffected': 24, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'L+M 2000 Fed', 'description': '5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.', 'otherNumAtRisk': 16, 'otherNumAffected': 8, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'FDC 2000 Fed', 'description': '5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.', 'otherNumAtRisk': 16, 'otherNumAffected': 5, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'L+M 2000 Fasted', 'description': '5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.'}, {'id': 'OG001', 'title': 'FDC 2000 Fasted', 'description': '5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.'}, {'id': 'OG002', 'title': 'L+M 2000 Fed', 'description': '5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.'}, {'id': 'OG003', 'title': 'FDC 2000 Fed', 'description': '5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '278.460', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '288.709', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '264.509', 'spread': '12.7', 'groupId': 'OG002'}, {'value': '268.814', 'spread': '12.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Geometric Means ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.68', 'ciLowerLimit': '100.703', 'ciUpperLimit': '106.747', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.018', 'estimateComment': 'Ratio of (FDC 2000 fasted/ L+M 2000 fasted)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'", 'testedNonInferiority': True, 'nonInferiorityComment': 'The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.'}, {'pValue': '0.0003', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted Geometric Means ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.63', 'ciLowerLimit': '93.721', 'ciUpperLimit': '110.202', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.047', 'estimateComment': 'Ratio of (FDC 2000 fed/ L+M 2000 fed)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.", 'testedNonInferiority': True, 'nonInferiorityComment': 'The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration', 'description': 'AUC 0-72 (area under the concentration-time curve of Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.'}, {'type': 'PRIMARY', 'title': 'Maximum Measured Concentration of Linagliptin in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'L+M 2000 Fasted', 'description': '5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.'}, {'id': 'OG001', 'title': 'FDC 2000 Fasted', 'description': '5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.'}, {'id': 'OG002', 'title': 'L+M 2000 Fed', 'description': '5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.'}, {'id': 'OG003', 'title': 'FDC 2000 Fed', 'description': '5 mg linagliptin and 2000 mg 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Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'L+M 2000 Fasted', 'description': '5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.'}, {'id': 'OG001', 'title': 'FDC 2000 Fasted', 'description': '5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.'}, {'id': 'OG002', 'title': 'L+M 2000 Fed', 'description': '5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.'}, {'id': 'OG003', 'title': 'FDC 2000 Fed', 'description': '5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '12028.27', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '11601.19', 'spread': '17.6', 'groupId': 'OG001'}, {'value': '20411.01', 'spread': '11.7', 'groupId': 'OG002'}, {'value': '19952.61', 'spread': '11.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Geometric Means ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.45', 'ciLowerLimit': '91.23', 'ciUpperLimit': '101.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.03', 'estimateComment': 'Ratio of (FDC 2000 fasted/ L+M 2000 fasted)', 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'sequence', 'subjects within sequences', 'period', and 'treatment'.", 'testedNonInferiority': True, 'nonInferiorityComment': 'The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration', 'description': 'AUC 0-tz (Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.'}, {'type': 'PRIMARY', 'title': 'Cmax of Metformin in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'L+M 2000 Fasted', 'description': '5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.'}, {'id': 'OG001', 'title': 'FDC 2000 Fasted', 'description': '5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.'}, {'id': 'OG002', 'title': 'L+M 2000 Fed', 'description': '5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.'}, {'id': 'OG003', 'title': 'FDC 2000 Fed', 'description': '5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '1516.558', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '1485.642', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '1571.040', 'spread': '13.8', 'groupId': 'OG002'}, {'value': '1662.954', 'spread': '13.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Geometric Means ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.96', 'ciLowerLimit': '92.046', 'ciUpperLimit': '104.257', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.038', 'estimateComment': 'Ratio of (FDC 2000 fasted/ L+M 2000 fasted)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'", 'testedNonInferiority': True, 'nonInferiorityComment': 'The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.'}, {'pValue': '0.0030', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted Geometric Means ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.85', 'ciLowerLimit': '96.705', 'ciUpperLimit': '115.861', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.053', 'estimateComment': 'Ratio of (FDC 2000 fed/ L+M 2000 fed)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.", 'testedNonInferiority': True, 'nonInferiorityComment': 'The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration', 'description': 'Cmax (maximum measured concentration of Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'L+M 2000 Fasted', 'description': '5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.'}, {'id': 'OG001', 'title': 'FDC 2000 Fasted', 'description': '5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.'}, {'id': 'OG002', 'title': 'L+M 2000 Fed', 'description': '5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.'}, {'id': 'OG003', 'title': 'FDC 2000 Fed', 'description': '5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '457.780', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '473.704', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '445.884', 'spread': '16.7', 'groupId': 'OG002'}, {'value': '451.888', 'spread': '16.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Geometric Means ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.48', 'ciLowerLimit': '98.426', 'ciUpperLimit': '108.790', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.030', 'estimateComment': 'Ratio of (FDC 2000 fasted/ L+M 2000 fasted)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'", 'testedNonInferiority': True, 'nonInferiorityComment': 'The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.'}, {'pValue': '0.0019', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted Geometric Means ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.35', 'ciLowerLimit': '91.130', 'ciUpperLimit': '112.708', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.062', 'estimateComment': 'Ratio of (FDC 2000 fed/ L+M 2000 fed)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.", 'testedNonInferiority': True, 'nonInferiorityComment': 'The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration', 'description': 'AUC0-inf (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.\n\nThe values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints'}, {'type': 'SECONDARY', 'title': 'AUC0-inf of Metformin in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'L+M 2000 Fasted', 'description': '5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.'}, {'id': 'OG001', 'title': 'FDC 2000 Fasted', 'description': '5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.'}, {'id': 'OG002', 'title': 'L+M 2000 Fed', 'description': '5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.'}, {'id': 'OG003', 'title': 'FDC 2000 Fed', 'description': '5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '12736.87', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '12162.37', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '20721.20', 'spread': '11.9', 'groupId': 'OG002'}, {'value': '20346.34', 'spread': '11.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Geometric Means ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.49', 'ciLowerLimit': '89.73', 'ciUpperLimit': '101.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.04', 'estimateComment': 'Ratio of (FDC 2000 fasted/ L+M 2000 fasted)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'", 'testedNonInferiority': True, 'nonInferiorityComment': 'The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.'}, {'pValue': '0.0002', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted Geometric Means ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.19', 'ciLowerLimit': '90.73', 'ciUpperLimit': '106.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.05', 'estimateComment': 'Ratio of (FDC 2000 fed/ L+M 2000 fed)', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': "ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.", 'testedNonInferiority': True, 'nonInferiorityComment': 'The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration', 'description': 'AUC0-inf(area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity) for Metformin.\n\nThe values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS 2000 fast and PKS 2000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FDC 2000 Fasted / L+M 2000 Fasted', 'description': 'Linagliptin+ Metformin Fixed dose combination (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin Extended Release (XR) (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.\n\nWhere, L+M = Linagliptin 5mg+Metformin XR 2000mg'}, {'id': 'FG001', 'title': 'L+M 2000 Fasted / FDC 2000 Fasted', 'description': 'Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after an overnight fast of at least 10 h.\n\nWhere, L+M = Linagliptin 5mg+Metformin XR 2000mg'}, {'id': 'FG002', 'title': 'FDC 2000 Fed / L+M 2000 Fed', 'description': 'Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after after a high-fat, high-calorie meal.\n\nWhere, L+M = Linagliptin 5mg+Metformin XR 2000mg'}, {'id': 'FG003', 'title': 'L+M 2000 Fed / FDC 2000 Fed', 'description': 'Linagliptin+ Metformin-(R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.\n\nWhere, L+M = Linagliptin 5mg+Metformin XR 2000mg'}], 'periods': [{'title': 'Treatment Period 1 (4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 1 (35 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted in two parts. Part 1: Fasting study Part 2: Fed Study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FDC 2000 Fasted or L+M 2000 Fasted', 'description': 'The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted\\_R fasted or R fasted\\_T fasted.\n\nFDC 2000 fasted (T fasted): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.\n\nL+M 2000 fasted (R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.\n\nWhere, L+M = Linagliptin 5mg+Metformin XR 2000mg'}, {'id': 'BG001', 'title': 'FDC 2000 Fed or L+M 2000 Fed', 'description': 'The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed\\_R fed or R fed\\_T fed.\n\nFDC 2000 fed (T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after a high-fat, high-calorie meal.\n\nL+M 2000 fed (R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.\n\nWhere, L+M = Linagliptin 5mg+Metformin XR 2000mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '32.6', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '33.0', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set: All randomised subjects who received 1 dose of trial medication were included in the treated set.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-23', 'studyFirstSubmitDate': '2014-03-07', 'resultsFirstSubmitDate': '2016-06-23', 'studyFirstSubmitQcDate': '2014-03-07', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-23', 'studyFirstPostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration', 'description': 'AUC 0-72 (area under the concentration-time curve of Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.'}, {'measure': 'Maximum Measured Concentration of Linagliptin in Plasma (Cmax)', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration', 'description': 'Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.'}, {'measure': 'Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration', 'description': 'AUC 0-tz (Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.'}, {'measure': 'Cmax of Metformin in Plasma', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration', 'description': 'Cmax (maximum measured concentration of Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration', 'description': 'AUC0-inf (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.\n\nThe values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.'}, {'measure': 'AUC0-inf of Metformin in Plasma', 'timeFrame': '1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration', 'description': 'AUC0-inf(area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity) for Metformin.\n\nThe values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing linagliptin and metformin extended release compared to the free combination of linagliptin and metformin extended release.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Healthy male or female subjects\n\nExclusion criteria:\n\n\\- Any relevant deviation from healthy condition'}, 'identificationModule': {'nctId': 'NCT02084056', 'briefTitle': 'Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release (2.5 mg/1000 mg) Compared With the Free Combination of Linagliptin and Metformin Extended Release Tablets in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Trial)', 'orgStudyIdInfo': {'id': '1288.11'}, 'secondaryIdInfos': [{'id': '2013-005144-28', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FDC first, fasted', 'description': 'Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fasted', 'interventionNames': ['Drug: Linagliptin', 'Drug: Metformin', 'Drug: Linagliptin/Metformin FDC']}, {'type': 'EXPERIMENTAL', 'label': 'Single tablets first, fasted', 'description': 'single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fasted', 'interventionNames': ['Drug: Linagliptin', 'Drug: Metformin', 'Drug: Linagliptin/Metformin FDC']}, {'type': 'EXPERIMENTAL', 'label': 'FDC first, fed', 'description': 'Linagliptin/Metformin FDC followed by single tablets of linagliptin and metformin, fed', 'interventionNames': ['Drug: Linagliptin', 'Drug: Metformin', 'Drug: Linagliptin/Metformin FDC']}, {'type': 'EXPERIMENTAL', 'label': 'Single tablets first, fed', 'description': 'single tablets of linagliptin and metformin followed by Linagliptin/Metformin FDC, fed', 'interventionNames': ['Drug: Linagliptin', 'Drug: Metformin', 'Drug: Linagliptin/Metformin FDC']}], 'interventions': [{'name': 'Linagliptin', 'type': 'DRUG', 'description': 'Linagliptin', 'armGroupLabels': ['FDC first, fasted', 'FDC first, fed', 'Single tablets first, fasted', 'Single tablets first, fed']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin', 'armGroupLabels': ['FDC first, fasted', 'FDC first, fed', 'Single tablets first, fasted', 'Single tablets first, fed']}, {'name': 'Linagliptin/Metformin FDC', 'type': 'DRUG', 'description': 'Linagliptin/Metformin FDC', 'armGroupLabels': ['FDC first, fasted', 'FDC first, fed', 'Single tablets first, fasted', 'Single tablets first, fed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Biberach', 'country': 'Germany', 'facility': '1288.11.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.33333, 'lon': 8.03333}}], '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'}}}}