Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT01311505
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2011-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012293', 'term': 'Rifampin'}, {'id': 'D007538', 'term': 'Isoniazid'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007539', 'term': 'Isonicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Myrin 2', 'description': 'Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Rimactane', 'description': 'Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC [0-t])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Myrin 2', 'description': 'Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.'}, {'id': 'OG001', 'title': 'Rimactane', 'description': 'Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.59', 'spread': '24.99', 'groupId': 'OG000'}, {'value': '38.81', 'spread': '21.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.90', 'ciLowerLimit': '92.98', 'ciUpperLimit': '105.20', 'groupDescription': '20 participants (10 per sequence) provided at least 98% power that 90% confidence interval (CI) for ratio of test to reference for AUC(0-t) of rifampicin lie within acceptance region of 80%-125%. Intra-participant coefficient of variation (CV) estimate of approximately 13.48% for AUC(0-t) was used for this power calculation. Natural log transformed AUC(0-t) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hours (hrs) post-dose', 'description': 'AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)', 'unitOfMeasure': 'microgram*hour/milliliter (mcg*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Myrin 2', 'description': 'Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.'}, {'id': 'OG001', 'title': 'Rimactane', 'description': 'Single oral dose of reference drug Rimactane capsule (300 mg capsule) in either first intervention period or second intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.89', 'spread': '24.89', 'groupId': 'OG000'}, {'value': '8.02', 'spread': '22.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.24', 'ciLowerLimit': '87.77', 'ciUpperLimit': '109.97', 'groupDescription': '20 participants (10 per sequence) provided at least 94% power that 90% CI for ratio of test to reference for Cmax of rifampicin lie within acceptance region of 80%-125%. Intra-participant CV estimate of approximately 16.43% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Myrin 2', 'description': 'Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.'}, {'id': 'OG001', 'title': 'Rimactane', 'description': 'Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose', 'unitOfMeasure': 'hrs', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Myrin 2', 'description': 'Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.'}, {'id': 'OG001', 'title': 'Rimactane', 'description': 'Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.72', 'spread': '30.54', 'groupId': 'OG000'}, {'value': '47.15', 'spread': '25.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.25', 'ciLowerLimit': '94.44', 'ciUpperLimit': '106.41', 'groupDescription': 'Natural log transformed AUC(0-∞) of rifampicin was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose', 'description': 'AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).', 'unitOfMeasure': 'mcg*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Myrin 2', 'description': 'Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.'}, {'id': 'OG001', 'title': 'Rimactane', 'description': 'Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0750', 'spread': '1.0777', 'groupId': 'OG000'}, {'value': '3.8635', 'spread': '0.8347', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Myrin 2', 'description': 'Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.'}, {'id': 'OG001', 'title': 'Rimactane', 'description': 'Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.84', 'spread': '38.47', 'groupId': 'OG000'}, {'value': '17.53', 'spread': '30.23', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose', 'description': 'AUC%extrapolated is the extrapolated area under the plasma concentration time profile following the last measured concentration. It is calculated as (AUC \\[0-∞\\] minus AUC\\[0-10\\])\\*100/ AUC (0-∞), where AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-10) = area under the plasma concentration time-curve from zero (pre-dose) to the last quantifiable concentration.', 'unitOfMeasure': 'Percent AUC', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Abnormal Safety Laboratory Test Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Myrin 2', 'description': 'Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.'}, {'id': 'OG001', 'title': 'Rimactane', 'description': 'Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening and Follow-up (1 week post-baseline)', 'description': 'Participants were evaluated for following safety laboratory tests: Hematology, chemistry, urinalysis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included participants who received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinically Significant Change From Baseline Supine Blood Pressure (BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Myrin 2', 'description': 'Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.'}, {'id': 'OG001', 'title': 'Rimactane', 'description': 'Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)', 'description': 'Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not summarized since supine systolic and diastolic BP remained within normal limits throughout the study and there were no significant deviations from baseline.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinically Significant Change From Baseline Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Myrin 2', 'description': 'Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.'}, {'id': 'OG001', 'title': 'Rimactane', 'description': 'Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)', 'description': 'Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not summarized since pulse rate remained within normal limits throughout the study and there were no significant deviations from baseline.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinically Significant Change From Baseline Oral Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Myrin 2', 'description': 'Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.'}, {'id': 'OG001', 'title': 'Rimactane', 'description': 'Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)', 'description': 'Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.', 'unitOfMeasure': 'Degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not summarized since oral temperature remained within normal limits throughout the study and there were no significant deviations from baseline.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clinically Significant Change From Baseline Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Myrin 2', 'description': 'Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.'}, {'id': 'OG001', 'title': 'Rimactane', 'description': 'Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)', 'description': 'Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.', 'unitOfMeasure': 'respirations/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not summarized since respiratory rate remained within normal limits throughout the study and there were no significant deviations from baseline.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Myrin 2', 'description': 'Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.'}, {'id': 'OG001', 'title': 'Rimactane', 'description': 'Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.'}], 'classes': [{'title': 'Day 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0), Day 1 and Follow-up (1 week post-baseline)', 'description': 'Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included participants who received at least 1 dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Myrin 2 First, Then Rimactane', 'description': 'Single oral dose of 2 fixed dose combination (FDC) tablets of Myrin 2 (each tablet contains 150 milligram (mg) rifampicin and 75 mg isoniazid) in first intervention period, and single oral dose of Rimactane capsule (300 mg rifampicin) in second intervention period. A washout period of at least 7 days was maintained between each period.'}, {'id': 'FG001', 'title': 'Rimactane First, Then Myrin 2', 'description': 'Single oral dose of Rimactane capsule (300 mg rifampicin) in first intervention period; and single oral dose of 2 FDC tablets of Myrin 2 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) in second intervention period. A washout period of at least 7 days was maintained between each period.'}], 'periods': [{'title': 'First Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Washout Period (at Least 7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Out of 22 participants enrolled, only 21 participants were randomized since 1 participant withdrew from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants Eligible for Analysis', 'description': 'Includes participants randomized to receive Myrin 2 first and Rimactane first and who had completed the study. It excludes 1 participant who did not meet the weight requirement for the study (protocol violator).'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 to 22 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '23 to 27 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '28 to 32 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '33 to 37 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-21', 'studyFirstSubmitDate': '2011-02-15', 'resultsFirstSubmitDate': '2012-03-23', 'studyFirstSubmitQcDate': '2011-03-07', 'lastUpdatePostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-21', 'studyFirstPostDateStruct': {'date': '2011-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Abnormal Safety Laboratory Test Values', 'timeFrame': 'Screening and Follow-up (1 week post-baseline)', 'description': 'Participants were evaluated for following safety laboratory tests: Hematology, chemistry, urinalysis.'}, {'measure': 'Clinically Significant Change From Baseline Supine Blood Pressure (BP)', 'timeFrame': 'Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)', 'description': 'Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.'}, {'measure': 'Clinically Significant Change From Baseline Pulse Rate', 'timeFrame': 'Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)', 'description': 'Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.'}, {'measure': 'Clinically Significant Change From Baseline Oral Temperature', 'timeFrame': 'Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)', 'description': 'Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.'}, {'measure': 'Clinically Significant Change From Baseline Respiratory Rate', 'timeFrame': 'Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)', 'description': 'Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline (Day 0), Day 1 and Follow-up (1 week post-baseline)', 'description': 'Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.'}], 'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC [0-t])', 'timeFrame': '0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hours (hrs) post-dose', 'description': 'AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose'}], 'secondaryOutcomes': [{'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])', 'timeFrame': '0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose', 'description': 'AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).'}, {'measure': 'Plasma Decay Half-life (t1/2)', 'timeFrame': '0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)', 'timeFrame': '0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose', 'description': 'AUC%extrapolated is the extrapolated area under the plasma concentration time profile following the last measured concentration. It is calculated as (AUC \\[0-∞\\] minus AUC\\[0-10\\])\\*100/ AUC (0-∞), where AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-10) = area under the plasma concentration time-curve from zero (pre-dose) to the last quantifiable concentration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioequivalence; rifampicin'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3801001&StudyName=Bioequivalence%20Study%20Comparing%20Rifampicin%20In%20A%20Fixed-Dose%20Combination%20%28Rifampicin+Isoniazid%2C%20Myrin%A9%202%29%20And%20The%20Reference%20Drug%20%28Rifampi', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2 Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer Inc) with equivalent dose of the reference Rimactane® capsule (each contains 300 mg rifampicin, Novartis Sandoz) in healthy Filipino male subjects. This study also aims to determine the safety and tolerability of Myrin© 2 tablets and Rimactane® capsules in these subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male subjects between the ages of 18 and 55 years, inclusive.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lbs).\n* An informed consent document signed and dated by the subject.\n* Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).\n* Any condition possibly affecting drug absorption (e.g., gastrectomy).\n* A positive urine drug screen.\n* History of regular alcohol consumption exceeding 21 drinks/week (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening.\n* Treatment with an investigational drug within 3 months (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.\n* 12-lead ECG demonstrating QTc \\>450 msec at screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.\n* History of previous treatment for TB or is suspected of suffering from TB.\n* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal medication, herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen / paracetamol may be used at doses of less than 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.\n* Blood donation of approximately 1 pint (500 ml) within 56 days prior to dosing.\n* A history of hypersensitivity to any of the study medications or related substances, or to any of the ingredients used in the study drug formulations.\n* Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.\n* Recent history of diarrhea (2 weeks).\n* Recent use of oral (2 weeks) or IV (2-3 months) antibiotics to assure normal bowel flora at study start."}, 'identificationModule': {'nctId': 'NCT01311505', 'briefTitle': 'Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open Label, Single Dose, Randomized, Two-Way Cross-Over Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination Rifampicin + Isoniazid (Myrin© 2, Pfizer Inc) Tablet With The Reference Drug (Rimactane®, Novartis Sandoz) Capsule In Healthy Filipino Male Subjects', 'orgStudyIdInfo': {'id': 'B3801001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Test', 'interventionNames': ['Drug: Myrin© 2 (Rifampicin + Isoniazid)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Reference', 'interventionNames': ['Drug: Rimactane® (Rifampicin)']}], 'interventions': [{'name': 'Myrin© 2 (Rifampicin + Isoniazid)', 'type': 'DRUG', 'otherNames': ['Myrin© 2 (Pfizer Inc.)'], 'description': 'Two (2) fixed-dose combination tablets each containing Rifampicin 150 mg and Isoniazid 75 mg', 'armGroupLabels': ['A']}, {'name': 'Rimactane® (Rifampicin)', 'type': 'DRUG', 'otherNames': ['Rimactane® (Novartis Sandoz)'], 'description': 'One (1) capsule of Rifampicin 300 mg', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4114', 'city': 'Dasmariñas', 'country': 'Philippines', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 14.32944, 'lon': 120.93667}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}