Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-27 @ 6:49 AM
Study NCT ID:
NCT02129192
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2014-04-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until end of washout period (14 days) or 144 hours after last drug administration (6 days)', 'eventGroups': [{'id': 'EG000', 'title': 'T80/A5/H12.5 mg FDC', 'description': 'Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet', 'otherNumAtRisk': 71, 'otherNumAffected': 11, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'T80/H12.5 FDC + A5 Capsule', 'description': 'Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule', 'otherNumAtRisk': 72, 'otherNumAffected': 6, 'seriousNumAtRisk': 72, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Total.', 'description': 'All participants randomised into the study.', 'otherNumAtRisk': 72, 'otherNumAffected': 16, 'seriousNumAtRisk': 72, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 72, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Measured Concentration (Cmax) of the Analytes in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5/H12.5 mg FDC', 'description': 'Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet'}, {'id': 'OG001', 'title': 'T80/H12.5 FDC + A5 Capsule', 'description': 'Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule'}], 'classes': [{'title': 'Telmisartan', 'categories': [{'measurements': [{'value': '697', 'spread': '75.5', 'groupId': 'OG000'}, {'value': '726', 'spread': '74.9', 'groupId': 'OG001'}]}]}, {'title': 'Amlodipine', 'categories': [{'measurements': [{'value': '3.62', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '19.9', 'groupId': 'OG001'}]}]}, {'title': 'HCTZ', 'categories': [{'measurements': [{'value': '98.5', 'spread': '25.1', 'groupId': 'OG000'}, {'value': '96.6', 'spread': '25.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.77', 'ciLowerLimit': '88.89', 'ciUpperLimit': '103.17', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.', 'groupDescription': 'Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Model on logarithmic scale included "subjects within sequence" as random effect and "sequence", "period", and "treatment" as fixed effects.', 'nonInferiorityComment': 'Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.40', 'ciLowerLimit': '99.70', 'ciUpperLimit': '103.13', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.', 'groupDescription': 'Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Model on logarithmic scale included "subjects within sequence" as random effect and "sequence", "period", and "treatment" as fixed effects.', 'nonInferiorityComment': 'Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.77', 'ciLowerLimit': '98.46', 'ciUpperLimit': '105.19', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.', 'groupDescription': 'Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Model on logarithmic scale included "subjects within sequence" as random effect and "sequence", "period", and "treatment" as fixed effects.', 'nonInferiorityComment': 'Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only', 'description': 'Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS) which included all healthy subjects in the TS who had evaluable PK variables for both treatments (i.e. had data of at least one analyte for both test and reference products) in periods 1, 2, 3 and 4. Subjects who had an important protocol violation relevant to PK evaluation were to be excluded from the PKS.'}, {'type': 'PRIMARY', 'title': 'Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5/H12.5 mg FDC Fed', 'description': 'Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fed condition'}, {'id': 'OG001', 'title': 'T80/A5/H12.5 FDC Fasted', 'description': 'Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fasted condition'}], 'classes': [{'title': 'Telmisartan', 'categories': [{'measurements': [{'value': '182', 'spread': '75.9', 'groupId': 'OG000'}, {'value': '605', 'spread': '84.4', 'groupId': 'OG001'}]}]}, {'title': 'Amlodipine', 'categories': [{'measurements': [{'value': '3.54', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '3.60', 'spread': '22.4', 'groupId': 'OG001'}]}]}, {'title': 'HCTZ', 'categories': [{'measurements': [{'value': '75.4', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '94.6', 'spread': '20.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '30.15', 'ciLowerLimit': '24.99', 'ciUpperLimit': '36.38', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.', 'groupDescription': 'Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included "subject" as random effect and "feeding condition" as fixed effect.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.23', 'ciLowerLimit': '94.63', 'ciUpperLimit': '101.97', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.', 'groupDescription': 'Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included "subject" as random effect and "feeding condition" as fixed effect.'}, {'pValue': '0.5422', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '79.69', 'ciLowerLimit': '74.97', 'ciUpperLimit': '84.71', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.', 'groupDescription': 'Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included "subject" as random effect and "feeding condition" as fixed effect.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only', 'description': 'Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma after single oral administration of T80/A5/H12.5 mg FDC tablet', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Food effect analysis set (FEAS) which included healthy subjects of treatment sequence TRRTT in the TS who were judged appropriate to continue to period 5 by the investigator, had evaluable PK variables for both feeding conditions and did not have an important protocol violation relevant to relative bioavailability evaluation.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5/H12.5 mg FDC', 'description': 'Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet'}, {'id': 'OG001', 'title': 'T80/H12.5 FDC + A5 Capsule', 'description': 'Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule'}], 'classes': [{'title': 'Telmisartan', 'categories': [{'measurements': [{'value': '2580', 'spread': '76.8', 'groupId': 'OG000'}, {'value': '2600', 'spread': '76.1', 'groupId': 'OG001'}]}]}, {'title': 'Amlodipine', 'categories': [{'measurements': [{'value': '159', 'spread': '23.4', 'groupId': 'OG000'}, {'value': '157', 'spread': '24.0', 'groupId': 'OG001'}]}]}, {'title': 'HCTZ', 'categories': [{'measurements': [{'value': '600', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '598', 'spread': '19.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.21', 'ciLowerLimit': '96.14', 'ciUpperLimit': '102.38', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.', 'groupDescription': 'Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Model on logarithmic scale included "subjects within sequence" as random effect and "sequence", "period", and "treatment" as fixed effects.', 'nonInferiorityComment': 'Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciPctValue': '90', 'paramValue': '101.43', 'ciLowerLimit': '99.84', 'ciUpperLimit': '103.04', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.', 'groupDescription': 'Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Model on logarithmic scale included "subjects within sequence" as random effect and "sequence", "period", and "treatment" as fixed effects.', 'nonInferiorityComment': 'Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.33', 'ciLowerLimit': '98.29', 'ciUpperLimit': '102.40', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.', 'groupDescription': 'Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Model on logarithmic scale included "subjects within sequence" as random effect and "sequence", "period", and "treatment" as fixed effects.', 'nonInferiorityComment': 'Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only', 'description': 'Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration After Single Administration of T80/A5/H12.5 mg FDC Tablet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5/H12.5 mg FDC Fed', 'description': 'Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fed condition'}, {'id': 'OG001', 'title': 'T80/A5/H12.5 FDC Fasted', 'description': 'Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fasted condition'}], 'classes': [{'title': 'Telmisartan', 'categories': [{'measurements': [{'value': '1500', 'spread': '98.3', 'groupId': 'OG000'}, {'value': '2350', 'spread': '93.6', 'groupId': 'OG001'}]}]}, {'title': 'Amlodipine', 'categories': [{'measurements': [{'value': '156', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '157', 'spread': '26.1', 'groupId': 'OG001'}]}]}, {'title': 'HCTZ', 'categories': [{'measurements': [{'value': '515', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '575', 'spread': '19.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '63.66', 'ciLowerLimit': '58.98', 'ciUpperLimit': '68.71', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.', 'groupDescription': 'Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included "subject" as random effect and "feeding condition" as fixed effect.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.74', 'ciLowerLimit': '97.08', 'ciUpperLimit': '102.48', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.', 'groupDescription': 'Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included "subject" as random effect and "feeding condition" as fixed effect.'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.66', 'ciLowerLimit': '85.80', 'ciUpperLimit': '93.70', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.', 'groupDescription': 'Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included "subject" as random effect and "feeding condition" as fixed effect.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only', 'description': 'Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration after single administration of T80/A5/H12.5 mg FDC tablet', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FEAS'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5/H12.5 mg FDC', 'description': 'Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet'}, {'id': 'OG001', 'title': 'T80/H12.5 FDC + A5 Capsule', 'description': 'Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule'}], 'classes': [{'title': 'Telmisartan ( N = 142, 142)', 'categories': [{'measurements': [{'value': '2750', 'spread': '79.2', 'groupId': 'OG000'}, {'value': '2730', 'spread': '73.7', 'groupId': 'OG001'}]}]}, {'title': 'Amlodipine ( N = 142, 142)', 'categories': [{'measurements': [{'value': '172', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '170', 'spread': '26.0', 'groupId': 'OG001'}]}]}, {'title': 'HCTZ ( N = 141, 142)', 'categories': [{'measurements': [{'value': '626', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '624', 'spread': '18.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.62', 'ciLowerLimit': '96.32', 'ciUpperLimit': '103.04', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.', 'groupDescription': 'Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Model on logarithmic scale included "subjects within sequence" as random effect and "sequence", "period", and "treatment" as fixed effects.', 'nonInferiorityComment': 'Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.21', 'ciLowerLimit': '99.59', 'ciUpperLimit': '102.87', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.', 'groupDescription': 'Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Model on logarithmic scale included "subjects within sequence" as random effect and "sequence", "period", and "treatment" as fixed effects.', 'nonInferiorityComment': 'Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.15', 'ciLowerLimit': '98.23', 'ciUpperLimit': '102.10', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.', 'groupDescription': 'Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Model on logarithmic scale included "subjects within sequence" as random effect and "sequence", "period", and "treatment" as fixed effects.', 'nonInferiorityComment': 'Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only', 'description': 'Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity After Single Administration of T80/A5/H12.5 mg FDC Tablet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T80/A5/H12.5 mg FDC Fed', 'description': 'Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fed condition'}, {'id': 'OG001', 'title': 'T80/A5/H12.5 FDC Fasted', 'description': 'Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fasted condition'}], 'classes': [{'title': 'Telmisartan ( N = 35, 36 )', 'categories': [{'measurements': [{'value': '1670', 'spread': '108.0', 'groupId': 'OG000'}, {'value': '2530', 'spread': '98.3', 'groupId': 'OG001'}]}]}, {'title': 'Amlodipine ( N = 36, 36 )', 'categories': [{'measurements': [{'value': '168', 'spread': '26.0', 'groupId': 'OG000'}, {'value': '169', 'spread': '28.6', 'groupId': 'OG001'}]}]}, {'title': 'HCTZ ( N = 36, 36 )', 'categories': [{'measurements': [{'value': '542', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '603', 'spread': '18.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '64.40', 'ciLowerLimit': '59.59', 'ciUpperLimit': '69.59', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.', 'groupDescription': 'Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included "subject" as random effect and "feeding condition" as fixed effect.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.45', 'ciLowerLimit': '96.69', 'ciUpperLimit': '102.29', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.', 'groupDescription': 'Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included "subject" as random effect and "feeding condition" as fixed effect.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.82', 'ciLowerLimit': '86.02', 'ciUpperLimit': '93.79', 'estimateComment': 'Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.', 'groupDescription': 'Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model included "subject" as random effect and "feeding condition" as fixed effect.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only', 'description': 'Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity after single administration of T80/A5/H12.5 mg FDC tablet', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'FEAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence TRRTT', 'description': 'Subjects were treated with telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 5:\n\nT (test product: T80/A5/H12.5 mg fixed dose combination (FDC) tablet) - R (reference products: T80/H12.5 mg FDC tablet and A5 mg capsule) - R - T - T.\n\nTreatment periods 1 to 4 were administered following an overnight fast of at least 10 hours, in treatment period 5 after an overnight fast of at least 10 hours, a Japanese-style breakfast was served 30 minutes before drug administration'}, {'id': 'FG001', 'title': 'Sequence RTTR', 'description': 'Subjects were treated telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 4:\n\nR - T - T - R.\n\nThe treatments were administered following an overnight fast of at least 10 hours.'}], 'periods': [{'title': 'Period 1 Including Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'comment': 'Withdrawal by one subject in washout period', 'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2 Including Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 3 Including Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 4 Including Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'comment': 'This sequence consists of only 4 periods.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence TRRTT', 'description': 'Subjects were treated with telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 5:\n\nT (test product: T80/A5/H12.5 mg fixed dose combination (FDC) tablet) - R (reference products: T80/H12.5 mg FDC tablet and A5 mg capsule) - R - T - T.\n\nTreatment periods 1 to 4 were administered following an overnight fast of at least 10 hours, in treatment period 5 after an overnight fast of at least 10 hours, a Japanese-style breakfast was served 30 minutes before drug administration'}, {'id': 'BG001', 'title': 'Sequence RTTR', 'description': 'Subjects were treated telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 4:\n\nR - T - T - R.\n\nThe treatments were administered following an overnight fast of at least 10 hours.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '26.6', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '26.6', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated Set (TS): This subject set included all subjects who were dispensed the study drug and were documented to have taken at least one dose of the study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2014-04-30', 'resultsFirstSubmitDate': '2016-10-06', 'studyFirstSubmitQcDate': '2014-04-30', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-01', 'studyFirstPostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Measured Concentration (Cmax) of the Analytes in Plasma', 'timeFrame': '3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only', 'description': 'Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma'}, {'measure': 'Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet', 'timeFrame': '3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only', 'description': 'Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma after single oral administration of T80/A5/H12.5 mg FDC tablet'}, {'measure': 'Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration', 'timeFrame': '3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only', 'description': 'Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration'}, {'measure': 'Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration After Single Administration of T80/A5/H12.5 mg FDC Tablet', 'timeFrame': '3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only', 'description': 'Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration after single administration of T80/A5/H12.5 mg FDC tablet'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity', 'timeFrame': '3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only', 'description': 'Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity'}, {'measure': 'Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity After Single Administration of T80/A5/H12.5 mg FDC Tablet', 'timeFrame': '3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only', 'description': 'Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity after single administration of T80/A5/H12.5 mg FDC tablet'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy male subjects age \\>=20 and \\<=35 years; body weight: \\>=50 kg and \\<=80 kg; body mass index: \\>=18.0 and \\<=25.0 kg/m2\n* Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature)\n* Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation\n\nExclusion criteria:\n\n\\- Any finding of the medical examination (including BP, PR and ECGs) deviating from normal and of clinical relevance'}, 'identificationModule': {'nctId': 'NCT02129192', 'briefTitle': 'Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Bioequivalence of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet Compared to Concomitant Administration of Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet and Amlodipine 5 mg Capsule in Healthy Male Subjects (an Open-label, Randomised, Single-dose, Two-sequence, Four-period Replicated Crossover Study), With Influence of Food on the Bioavailability of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed-dose Combination Tablet', 'orgStudyIdInfo': {'id': '1348.4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T80/A5/H12.5 mg FDC', 'description': 'Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet', 'interventionNames': ['Drug: T80/A5/H12.5 mg FDC tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'T80/H12.5 FDC + A5 mono', 'description': 'Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule', 'interventionNames': ['Drug: Amlodipine 5mg capsule', 'Drug: T80/H12.5 mg FDC tablet']}], 'interventions': [{'name': 'Amlodipine 5mg capsule', 'type': 'DRUG', 'description': 'Amlodipine 5mg capsule', 'armGroupLabels': ['T80/H12.5 FDC + A5 mono']}, {'name': 'T80/H12.5 mg FDC tablet', 'type': 'DRUG', 'description': 'Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg FDC tablet', 'armGroupLabels': ['T80/H12.5 FDC + A5 mono']}, {'name': 'T80/A5/H12.5 mg FDC tablet', 'type': 'DRUG', 'description': 'Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg FDC tablet', 'armGroupLabels': ['T80/A5/H12.5 mg FDC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo, Hachioji', 'country': 'Japan', 'facility': 'Boehringer Ingelheim Investigational Site'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}