Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-04-11 @ 6:02 AM
Study NCT ID:
NCT01703858
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2012-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077402', 'term': 'Pantoprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until 14 days after the last drug administration, up to 42 days.', 'eventGroups': [{'id': 'EG000', 'title': 'A : BI-113608', 'description': 'Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.', 'otherNumAtRisk': 15, 'otherNumAffected': 6, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'B : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.', 'otherNumAtRisk': 15, 'otherNumAffected': 6, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'C : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.', 'otherNumAtRisk': 15, 'otherNumAffected': 7, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Pantoprazole 40mg', 'description': 'Participants received single dose of Pantoprazole 40mg alone twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.', 'otherNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'D : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.', 'otherNumAtRisk': 15, 'otherNumAffected': 4, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'E : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.', 'otherNumAtRisk': 14, 'otherNumAffected': 5, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'A : BI-113608', 'description': 'Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.'}, {'id': 'OG001', 'title': 'B : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.'}, {'id': 'OG002', 'title': 'C : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.'}, {'id': 'OG003', 'title': 'D : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.'}, {'id': 'OG004', 'title': 'E : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.'}], 'classes': [{'categories': [{'measurements': [{'value': '936', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '924', 'spread': '31.2', 'groupId': 'OG001'}, {'value': '648', 'spread': '39.3', 'groupId': 'OG002'}, {'value': '900', 'spread': '32.7', 'groupId': 'OG003'}, {'value': '759', 'spread': '27.1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.68', 'ciLowerLimit': '92.501', 'ciUpperLimit': '105.272', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '10.0', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'B : BI-113608 vs. A : BI-113608 - Comparison with oral solution', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}, {'pValue': '0.9644', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '70.16', 'ciLowerLimit': '62.331', 'ciUpperLimit': '78.962', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '18.3', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'C : BI-113608 vs. B : BI-113608 - Food effect', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}, {'pValue': '0.2835', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '83.36', 'ciLowerLimit': '73.648', 'ciUpperLimit': '94.346', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '18.8', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'E : BI-113608 vs. B : BI-113608 - Food effect', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}, {'pValue': '0.1599', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '117.18', 'ciLowerLimit': '104.923', 'ciUpperLimit': '130.867', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '16.7', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'E : BI-113608 vs. C : BI-113608 - Food effect', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}, {'pValue': '0.0020', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.40', 'ciLowerLimit': '88.072', 'ciUpperLimit': '107.719', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '15.8', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'D : BI-113608 vs. B : BI-113608 - Pantoprazole effect', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.', 'description': 'Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).', 'unitOfMeasure': 'nanomol (nmol)* hours (h) / Litre (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.'}, {'type': 'PRIMARY', 'title': 'Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'A : BI-113608', 'description': 'Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.'}, {'id': 'OG001', 'title': 'B : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.'}, {'id': 'OG002', 'title': 'C : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.'}, {'id': 'OG003', 'title': 'D : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.'}, {'id': 'OG004', 'title': 'E : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.'}], 'classes': [{'categories': [{'measurements': [{'value': '271', 'spread': '44.6', 'groupId': 'OG000'}, {'value': '242', 'spread': '47.5', 'groupId': 'OG001'}, {'value': '132', 'spread': '77.8', 'groupId': 'OG002'}, {'value': '196', 'spread': '50.0', 'groupId': 'OG003'}, {'value': '227', 'spread': '53.1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1261', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.26', 'ciLowerLimit': '75.893', 'ciUpperLimit': '104.973', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '25.3', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'B : BI-113608 vs. A : BI-113608 - Comparison with oral solution', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}, {'pValue': '0.9808', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '54.57', 'ciLowerLimit': '40.711', 'ciUpperLimit': '73.157', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '47.4', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'C : BI-113608 vs. B : BI-113608 - Food effect', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}, {'pValue': '0.1449', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.88', 'ciLowerLimit': '72.175', 'ciUpperLimit': '124.731', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '43.2', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'E : BI-113608 vs. B : BI-113608 - Food effect', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}, {'pValue': '0.9463', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '169.46', 'ciLowerLimit': '124.093', 'ciUpperLimit': '231.419', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '49.7', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'E : BI-113608 vs. C : BI-113608 - Food effect', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}, {'pValue': '0.4564', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '81.06', 'ciLowerLimit': '65.811', 'ciUpperLimit': '99.848', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '33.3', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'D : BI-113608 vs. B : BI-113608 - Pantoprazole effect', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.', 'description': 'Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'A : BI-113608', 'description': 'Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.'}, {'id': 'OG001', 'title': 'B : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.'}, {'id': 'OG002', 'title': 'C : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.'}, {'id': 'OG003', 'title': 'D : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.'}, {'id': 'OG004', 'title': 'E : BI-113608', 'description': 'Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.'}], 'classes': [{'categories': [{'measurements': [{'value': '938', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '926', 'spread': '31.2', 'groupId': 'OG001'}, {'value': '650', 'spread': '39.3', 'groupId': 'OG002'}, {'value': '902', 'spread': '32.7', 'groupId': 'OG003'}, {'value': '761', 'spread': '27.1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.66', 'ciLowerLimit': '92.500', 'ciUpperLimit': '105.225', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '9.9', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'B : BI-113608 vs. A : BI-113608 - Comparison with oral solution', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}, {'pValue': '0.9635', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '70.24', 'ciLowerLimit': '62.430', 'ciUpperLimit': '79.038', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '18.3', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'C : BI-113608 vs. B : BI-113608 - Food effect', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}, {'pValue': '0.2771', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '83.46', 'ciLowerLimit': '73.774', 'ciUpperLimit': '94.412', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '18.7', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'E : BI-113608 vs. B : BI-113608 - Food effect', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}, {'pValue': '0.1584', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '117.16', 'ciLowerLimit': '104.958', 'ciUpperLimit': '130.787', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '16.6', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'E : BI-113608 vs. C : BI-113608 - Food effect', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}, {'pValue': '0.0020', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of Geometric means (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.41', 'ciLowerLimit': '88.066', 'ciUpperLimit': '107.741', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '15.8', 'estimateComment': 'Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.', 'groupDescription': 'D : BI-113608 vs. B : BI-113608 - Pantoprazole effect', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.', 'description': 'Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A - C - B - D - E', 'description': 'Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.'}, {'id': 'FG001', 'title': 'B - A - C - D - E', 'description': 'Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.'}, {'id': 'FG002', 'title': 'C - B - A - D - E', 'description': 'Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'An open label, randomised, single dose, 3-way cross-over study to investigate relative bioavailability and food effect on different formulations of Boehringer-Ingelheim (BI) -113608 in healthy male subjects, followed by fixed sequence periods investigating influence of pantoprazole coadministration and food effect on pharmacokinetics of BI-113608.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'A - C - B - D - E', 'description': 'Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.'}, {'id': 'BG001', 'title': 'B - A - C - D - E', 'description': 'Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.'}, {'id': 'BG002', 'title': 'C - B - A - D - E', 'description': 'Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.4', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '40.8', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '41.8', 'spread': '7.9', 'groupId': 'BG002'}, {'value': '40.7', 'spread': '7.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set (TS): All subjects those who received at least 1 dose of study drug were included in the in the treated set.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-23', 'studyFirstSubmitDate': '2012-10-08', 'resultsFirstSubmitDate': '2016-11-23', 'studyFirstSubmitQcDate': '2012-10-08', 'lastUpdatePostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-23', 'studyFirstPostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)', 'timeFrame': 'PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.', 'description': 'Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).'}, {'measure': 'Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)', 'timeFrame': 'PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.', 'description': 'Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)', 'timeFrame': 'PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.', 'description': 'Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of the trial is to investigate the relative bioavailability, influence of pantoprazole coadministration and food effect of different oral formulations of BI 113608 in healthy male subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1\\. healthy male subjects\n\nExclusion criteria:\n\n1\\. Any relevant deviation from healthy conditions'}, 'identificationModule': {'nctId': 'NCT01703858', 'briefTitle': 'Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'An Open Label, Randomised, Single Dose, 3-way Cross Over Study to Investigate Relative Bioavailability and Food Effect on Different Formulations of BI 113608 in Healthy Male Subjects, Followed by Fixed Sequence Periods Investigating Influence of Pantoprazole Coadministration and Food Effect on Pharmacokinetics of Different Formulations of BI 113608', 'orgStudyIdInfo': {'id': '1314.3'}, 'secondaryIdInfos': [{'id': '2012-002537-11', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 BI 113608', 'description': 'powder in the bottle for oral solution, oral administration with 240 mL water', 'interventionNames': ['Drug: BI 113608 PIB']}, {'type': 'EXPERIMENTAL', 'label': '2 BI 113608', 'description': 'conventional tablet formulation', 'interventionNames': ['Drug: BI 113608']}, {'type': 'EXPERIMENTAL', 'label': '3 BI 113608', 'description': 'conventional tablet formulation, fed', 'interventionNames': ['Drug: BI 113608']}, {'type': 'EXPERIMENTAL', 'label': '4 BI 113608', 'description': 'conventional tablet after pantoprazole administration', 'interventionNames': ['Drug: pantoprazole 40 mg STADA', 'Drug: BI 113608']}, {'type': 'EXPERIMENTAL', 'label': '5 BI 113608', 'description': 'conventional tablet formulation, fasted, 0:30 min before fat breakfast', 'interventionNames': ['Drug: BI 113608']}], 'interventions': [{'name': 'BI 113608 PIB', 'type': 'DRUG', 'description': 'powder for oral solution', 'armGroupLabels': ['1 BI 113608']}, {'name': 'BI 113608', 'type': 'DRUG', 'description': 'conventional tablet formulation', 'armGroupLabels': ['2 BI 113608']}, {'name': 'BI 113608', 'type': 'DRUG', 'description': 'conventional tablet formulation', 'armGroupLabels': ['3 BI 113608']}, {'name': 'BI 113608', 'type': 'DRUG', 'description': 'conventional tablet formulation', 'armGroupLabels': ['5 BI 113608']}, {'name': 'pantoprazole 40 mg STADA', 'type': 'DRUG', 'description': 'film-coated tablet', 'armGroupLabels': ['4 BI 113608']}, {'name': 'BI 113608', 'type': 'DRUG', 'description': 'conventional tablet formulation', 'armGroupLabels': ['4 BI 113608']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ingelheim', 'country': 'Germany', 'facility': '1314.3.1 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.97078, 'lon': 8.05883}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}