Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT01276327
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2011-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069476', 'term': 'Linagliptin'}, {'id': 'D000077205', 'term': 'Pioglitazone'}], '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': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': True, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 days treatment period (one day for every single dose), 35 days washout between drug administrations', 'description': 'Treated set included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of any study drug. Drug administrations were separated by washout periods of at least 35 days.', 'eventGroups': [{'id': 'EG000', 'title': 'FDC L5P30 (Test)', 'description': 'Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast', 'otherNumAtRisk': 62, 'otherNumAffected': 13, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'L5+P30 (Ref)', 'description': 'Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast', 'otherNumAtRisk': 63, 'otherNumAffected': 7, 'seriousNumAtRisk': 63, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}], 'seriousEvents': [{'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'AUC0-72 of Linagliptin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC L5P30 (Test)', 'description': 'Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast'}, {'id': 'OG001', 'title': 'L5+P30 (Ref)', 'description': 'Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast'}], 'classes': [{'categories': [{'measurements': [{'value': '278', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '279', 'spread': '20.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean Ratio (Test/Ref) (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.92', 'ciLowerLimit': '97.11', 'ciUpperLimit': '102.81', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.02', 'estimateComment': 'Geometric standard error of mean was calculated.', 'statisticalMethod': 'Unscaled average Bioequivalence', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Cmax of Linagliptin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC L5P30 (Test)', 'description': 'Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast'}, {'id': 'OG001', 'title': 'L5+P30 (Ref)', 'description': 'Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast'}], 'classes': [{'categories': [{'measurements': [{'value': '8.65', 'spread': '33.3', 'groupId': 'OG000'}, {'value': '9.09', 'spread': '31.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean Ratio (Test/Ref) (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.17', 'ciLowerLimit': '89.08', 'ciUpperLimit': '99.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.03', 'estimateComment': 'Geometric Standard error of mean was calculated.', 'statisticalMethod': 'Unscaled average Bioequivalence', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'AUC0-tz of Pioglitazone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC L5P30 (Test)', 'description': 'Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast'}, {'id': 'OG001', 'title': 'L5+P30 (Ref)', 'description': 'Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast'}], 'classes': [{'categories': [{'measurements': [{'value': '6370', 'spread': '49.3', 'groupId': 'OG000'}, {'value': '8100', 'spread': '41.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean Ratio (Test/Ref) (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '79.99', 'ciLowerLimit': '74.65', 'ciUpperLimit': '85.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.04', 'estimateComment': 'Geometric Standard error of mean was calculated.', 'statisticalMethod': 'Scaled average bioequivalence (SABE)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Cmax of Pioglitazone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC L5P30 (Test)', 'description': 'Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast'}, {'id': 'OG001', 'title': 'L5+P30 (Ref)', 'description': 'Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast'}], 'classes': [{'categories': [{'measurements': [{'value': '806', 'spread': '58.5', 'groupId': 'OG000'}, {'value': '843', 'spread': '42.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean Ratio (Test/Ref) (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.31', 'ciLowerLimit': '88.90', 'ciUpperLimit': '106.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.06', 'estimateComment': 'Geometric standard error of mean was calculated.', 'statisticalMethod': 'Scaled average bioequivalence (SABE)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'AUC0-tz for Linagliptin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC L5P30 (Test)', 'description': 'Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast'}, {'id': 'OG001', 'title': 'L5+P30 (Ref)', 'description': 'Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast'}], 'classes': [{'categories': [{'measurements': [{'value': '278', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '279', 'spread': '20.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean Ratio (Test/Ref) (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.92', 'ciLowerLimit': '97.10', 'ciUpperLimit': '102.81', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.02', 'estimateComment': 'Geometric Standard error of mean was calculated.', 'statisticalMethod': 'Unscaled average bioequivalence', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point for Linagliptin', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'AUC0-∞ of Linagliptin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC L5P30 (Test)', 'description': 'Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast'}, {'id': 'OG001', 'title': 'L5+P30 (Ref)', 'description': 'Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast'}], 'classes': [{'categories': [{'measurements': [{'value': '455', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '447', 'spread': '24.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean Ratio (Test/Ref) (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.85', 'ciLowerLimit': '98.18', 'ciUpperLimit': '105.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.02', 'estimateComment': 'Geometric standard error of mean was calculated.', 'statisticalMethod': 'Unscaled average bioequivalence', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'AUC0-∞ of Pioglitazone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC L5P30 (Test)', 'description': 'Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast'}, {'id': 'OG001', 'title': 'L5+P30 (Ref)', 'description': 'Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast'}], 'classes': [{'categories': [{'measurements': [{'value': '6580', 'spread': '47.5', 'groupId': 'OG000'}, {'value': '8300', 'spread': '40.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted gMean Ratio (Test/Ref) (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '80.79', 'ciLowerLimit': '75.60', 'ciUpperLimit': '86.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.04', 'estimateComment': 'Geometric standard error of mean was calculated.', 'statisticalMethod': 'Scaled average bioequivalence (SABE)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Tmax for Linagliptin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC L5P30 (Test)', 'description': 'Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast'}, {'id': 'OG001', 'title': 'L5+P30 (Ref)', 'description': 'Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast'}], 'classes': [{'categories': [{'measurements': [{'value': '1.73', 'groupId': 'OG000', 'lowerLimit': '0.667', 'upperLimit': '6.93'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '0.577', 'upperLimit': '6.93'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Tmax for Pioglitazone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FDC L5P30 (Test)', 'description': 'Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast'}, {'id': 'OG001', 'title': 'L5+P30 (Ref)', 'description': 'Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.667', 'upperLimit': '5.66'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '0.650', 'upperLimit': '4.90'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS - The PKS included all evaluable subjects in the treated set who had no important PV relevant to the evaluation of bioequivalence and provided at least 1 evaluable observation for a pharmacokinetic endpoint in at least 1 treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence TRTR', 'description': 'Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR.'}, {'id': 'FG001', 'title': 'Sequence RTRT', 'description': 'Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence TRTR', 'description': 'Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR.'}, {'id': 'BG001', 'title': 'Sequence RTRT', 'description': 'Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '38.0', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'TS - The treated set included all subjects who were dispensed study medication and were documented to have taken at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2014-06-03', 'studyFirstSubmitDate': '2011-01-12', 'resultsFirstSubmitDate': '2014-03-12', 'studyFirstSubmitQcDate': '2011-01-12', 'lastUpdatePostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-12', 'studyFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-72 of Linagliptin', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours'}, {'measure': 'Cmax of Linagliptin', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Maximum measured concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were reported.'}, {'measure': 'AUC0-tz of Pioglitazone', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point'}, {'measure': 'Cmax of Pioglitazone', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Maximum concentration of the analyte in plasma was measured. Adjusted by-treatment geometric mean and CV were calculated.'}], 'secondaryOutcomes': [{'measure': 'AUC0-tz for Linagliptin', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point for Linagliptin'}, {'measure': 'AUC0-∞ of Linagliptin', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to infinity (inf) for linagliptin'}, {'measure': 'AUC0-∞ of Pioglitazone', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 hours extrapolated to inf for pioglitazone'}, {'measure': 'Tmax for Linagliptin', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Time from dosing to the maximum measured concentration of the analyte in plasma for Linagliptin'}, {'measure': 'Tmax for Pioglitazone', 'timeFrame': '0-72 hours (measurements at baseline, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 8, 11, 12, 24, 48 and 72 hours)', 'description': 'Time from dosing to the maximum measured concentration of the analyte in plasma for pioglitazone'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 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': 'NCT01276327', 'briefTitle': 'Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Bioequivalence of a Fixed Dose Combination Tablet of Linagliptin 5 mg / Pioglitazone 30 mg Compared With Its Mono-components in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Replicate Design Study With Two Treatments in Four Crossover Periods)', 'orgStudyIdInfo': {'id': '1264.14'}, 'secondaryIdInfos': [{'id': '2010-022649-29', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Linagliptin/Pioglitazone (Test)', 'description': 'Fixed-Dose-Combination-Tablet, oral administration with 240 mL water', 'interventionNames': ['Drug: Linagliptin/Pioglitazone']}, {'type': 'EXPERIMENTAL', 'label': '2 Linagliptin + Pioglitazone (Ref)', 'description': 'Tablets, oral administration with 240 mL water for each treatment', 'interventionNames': ['Drug: Linagliptin + Pioglitazone']}, {'type': 'EXPERIMENTAL', 'label': '3 Linagliptin/Pioglitazone (Test)', 'description': 'Fixed-Dose-Combination-Tablet, oral administration with 240 mL water', 'interventionNames': ['Drug: Linagliptin/Pioglitazone']}, {'type': 'EXPERIMENTAL', 'label': '4 Linagliptin + Pioglitazone (Ref)', 'description': 'Tablets, oral administration with 240 mL water for each treatment', 'interventionNames': ['Drug: Linagliptin + Pioglitazone']}], 'interventions': [{'name': 'Linagliptin + Pioglitazone', 'type': 'DRUG', 'description': 'Medium doses, oral administration', 'armGroupLabels': ['2 Linagliptin + Pioglitazone (Ref)']}, {'name': 'Linagliptin + Pioglitazone', 'type': 'DRUG', 'description': 'Medium doses, oral administration', 'armGroupLabels': ['4 Linagliptin + Pioglitazone (Ref)']}, {'name': 'Linagliptin/Pioglitazone', 'type': 'DRUG', 'description': 'Medium dose oral administration', 'armGroupLabels': ['1 Linagliptin/Pioglitazone (Test)']}, {'name': 'Linagliptin/Pioglitazone', 'type': 'DRUG', 'description': 'Medium dose oral administration', 'armGroupLabels': ['3 Linagliptin/Pioglitazone (Test)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Biberach', 'country': 'Germany', 'facility': '1264.14.1 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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}