Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-02-28 @ 9:04 PM
Study NCT ID:
NCT02101112
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2014-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioavailability of Apixaban Crushed Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to May 2014; approximately 6 weeks F', 'description': 'Study initiated: March 2014; Study Completion: May 2014', 'eventGroups': [{'id': 'EG000', 'title': 'Apixaban, 10 mg (Whole Tablets)', 'description': 'Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Apixaban, 10 mg (Crushed and Suspended in Water)', 'description': 'Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Apixaban, 10 mg (Crushed and Mixed With Applesauce)', 'description': 'Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban, 10 mg (Whole Tablets)', 'description': 'Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.'}, {'id': 'OG001', 'title': 'Apixaban, 10 mg (Crushed and Suspended in Water)', 'description': 'Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.'}, {'id': 'OG002', 'title': 'Apixaban, 10 mg (Crushed and Mixed With Applesauce)', 'description': 'Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce'}], 'classes': [{'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000', 'lowerLimit': '217', 'upperLimit': '256'}, {'value': '249', 'groupId': 'OG001', 'lowerLimit': '232', 'upperLimit': '266'}, {'value': '186', 'groupId': 'OG002', 'lowerLimit': '174', 'upperLimit': '199'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.054', 'ciLowerLimit': '0.994', 'ciUpperLimit': '1.118', 'groupDescription': 'Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.788', 'ciLowerLimit': '0.741', 'ciUpperLimit': '0.839', 'groupDescription': 'Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 and 72 hours post dose', 'description': 'Maximum observed plasma concentration (Cmax) measured in nanograms per milliliter (ng/mL)', 'unitOfMeasure': 'ng/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable pharmacokinetic (PK) participants who were treated with apixaban'}, {'type': 'PRIMARY', 'title': 'Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban, 10 mg (Whole Tablets)', 'description': 'Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.'}, {'id': 'OG001', 'title': 'Apixaban, 10 mg (Crushed and Suspended in Water)', 'description': 'Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.'}, {'id': 'OG002', 'title': 'Apixaban, 10 mg (Crushed and Mixed With Applesauce)', 'description': 'Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce'}], 'classes': [{'categories': [{'measurements': [{'value': '2461', 'groupId': 'OG000', 'lowerLimit': '2273', 'upperLimit': '2664'}, {'value': '2528', 'groupId': 'OG001', 'lowerLimit': '2375', 'upperLimit': '2692'}, {'value': '2055', 'groupId': 'OG002', 'lowerLimit': '1915', 'upperLimit': '2206'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.027', 'ciLowerLimit': '0.981', 'ciUpperLimit': '1.076', 'groupDescription': 'Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.835', 'ciLowerLimit': '0.797', 'ciUpperLimit': '0.875', 'groupDescription': 'Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose', 'description': 'Area Under the Plasma Concentration-time Curve (AUC) From Time of Zero Extrapolated to Infinite Time (INF) \\[AUC (INF)\\] is measured as nanograms multiplied by hours per milliliter (ng\\*h/mL)', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable pharmacokinetic (PK) participants who were treated with apixaban'}, {'type': 'PRIMARY', 'title': 'Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban, 10 mg (Whole Tablets)', 'description': 'Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.'}, {'id': 'OG001', 'title': 'Apixaban, 10 mg (Crushed and Suspended in Water)', 'description': 'Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.'}, {'id': 'OG002', 'title': 'Apixaban, 10 mg (Crushed and Mixed With Applesauce)', 'description': 'Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce'}], 'classes': [{'categories': [{'measurements': [{'value': '2423', 'groupId': 'OG000', 'lowerLimit': '2238', 'upperLimit': '2623'}, {'value': '2488', 'groupId': 'OG001', 'lowerLimit': '2336', 'upperLimit': '2651'}, {'value': '2015', 'groupId': 'OG002', 'lowerLimit': '1876', 'upperLimit': '2165'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.027', 'ciLowerLimit': '0.981', 'ciUpperLimit': '1.075', 'groupDescription': 'Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.832', 'ciLowerLimit': '0.794', 'ciUpperLimit': '0.871', 'groupDescription': 'Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose', 'description': 'Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Concentration \\[AUC (0-T)\\] is measured as nanograms multiplied by hours per milliliter (ng\\*h/mL)', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable pharmacokinetic (PK) participants who were treated with apixaban'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban, 10 mg (Whole Tablets)', 'description': 'Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.'}, {'id': 'OG001', 'title': 'Apixaban, 10 mg (Crushed and Suspended in Water)', 'description': 'Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.'}, {'id': 'OG002', 'title': 'Apixaban, 10 mg (Crushed and Mixed With Applesauce)', 'description': 'Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Drug-related AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Discontinuation due to AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to May 2014; approximately 6 weeks', 'description': 'Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious Adverse Event (SAE)= a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban, 10 mg (Whole Tablets)', 'description': 'Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.'}, {'id': 'OG001', 'title': 'Apixaban, 10 mg (Crushed and Suspended in Water)', 'description': 'Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.'}, {'id': 'OG002', 'title': 'Apixaban, 10 mg (Crushed and Mixed With Applesauce)', 'description': 'Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '5.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '0.583', 'upperLimit': '4.00'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose', 'description': 'Time of maximum observed plasma concentration (Tmax) measured in hours (h)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable pharmacokinetic (PK) participants who were treated with apixaban'}, {'type': 'SECONDARY', 'title': 'Terminal Plasma Half-life (T-HALF) of Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban, 10 mg (Whole Tablets)', 'description': 'Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.'}, {'id': 'OG001', 'title': 'Apixaban, 10 mg (Crushed and Suspended in Water)', 'description': 'Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.'}, {'id': 'OG002', 'title': 'Apixaban, 10 mg (Crushed and Mixed With Applesauce)', 'description': 'Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'spread': '5.39', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '5.19', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '5.05', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose', 'description': 'Terminal plasma half-life (T-HALF) was derived from plasma concentration versus time data. T-HALF was the time required for one half of the total amount of administered drug to be eliminated from the body.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable pharmacokinetic (PK) participants who were treated with apixaban'}, {'type': 'SECONDARY', 'title': 'Relative Bioavailability (Frel) of Apixaban', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban, 10 mg (Crushed and Suspended in Water)', 'description': 'Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.'}, {'id': 'OG001', 'title': 'Apixaban, 10 mg (Crushed and Mixed With Applesauce)', 'description': 'Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'spread': '24', 'groupId': 'OG000'}, {'value': '0.836', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose', 'description': 'Frel is calculated using the treatment ratio of AUC(INF) where the denominator is the AUC(INF) of the reference therapy, 10mg of Apixaban (whole tablet).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All evaluable pharmacokinetic (PK) participants who were treated with apixaban'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment A Then Treatment B Then Treatment C', 'description': 'Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.\n\nTreatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.\n\nTreatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce\n\nThis was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.'}, {'id': 'FG001', 'title': 'Treatment A Then Treatment C Then Treatment B', 'description': 'Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.\n\nTreatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.\n\nTreatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce\n\nThis was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.'}, {'id': 'FG002', 'title': 'Treatment B Then Treatment C Then Treatment A', 'description': 'Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.\n\nTreatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.\n\nTreatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce\n\nThis was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.'}, {'id': 'FG003', 'title': 'Treatment B Then Treatment A Then Treatment C', 'description': 'Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.\n\nTreatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.\n\nTreatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce\n\nThis was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.'}, {'id': 'FG004', 'title': 'Treatment C Then Treatment A Then Treatment B', 'description': 'Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.\n\nTreatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.\n\nTreatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce\n\nThis was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.'}, {'id': 'FG005', 'title': 'Treatment C Then Treatment B Then Treatment A', 'description': 'Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.\n\nTreatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.\n\nTreatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce\n\nThis was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '69 participants enrolled, 33 participants randomized. 36 participants were enrolled but not randomized. Reasons for non-randomization include 30 participants no longer met study criteria, 4 participants withdrew consent, 2 participants were not needed for the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Apixaban, 10 mg (Whole Tablets)', 'description': 'This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'spread': '7.35', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '77.40', 'spread': '7.933', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '172.13', 'spread': '8.322', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.14', 'spread': '2.166', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms per meter^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-29', 'studyFirstSubmitDate': '2014-03-28', 'resultsFirstSubmitDate': '2016-02-29', 'studyFirstSubmitQcDate': '2014-03-28', 'lastUpdatePostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-29', 'studyFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban', 'timeFrame': 'Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 and 72 hours post dose', 'description': 'Maximum observed plasma concentration (Cmax) measured in nanograms per milliliter (ng/mL)'}, {'measure': 'Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban', 'timeFrame': 'Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose', 'description': 'Area Under the Plasma Concentration-time Curve (AUC) From Time of Zero Extrapolated to Infinite Time (INF) \\[AUC (INF)\\] is measured as nanograms multiplied by hours per milliliter (ng\\*h/mL)'}, {'measure': 'Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban', 'timeFrame': 'Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose', 'description': 'Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Concentration \\[AUC (0-T)\\] is measured as nanograms multiplied by hours per milliliter (ng\\*h/mL)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion', 'timeFrame': 'Randomization to May 2014; approximately 6 weeks', 'description': 'Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious Adverse Event (SAE)= a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.'}, {'measure': 'Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban', 'timeFrame': 'Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose', 'description': 'Time of maximum observed plasma concentration (Tmax) measured in hours (h)'}, {'measure': 'Terminal Plasma Half-life (T-HALF) of Apixaban', 'timeFrame': 'Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose', 'description': 'Terminal plasma half-life (T-HALF) was derived from plasma concentration versus time data. T-HALF was the time required for one half of the total amount of administered drug to be eliminated from the body.'}, {'measure': 'Relative Bioavailability (Frel) of Apixaban', 'timeFrame': 'Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose', 'description': 'Frel is calculated using the treatment ratio of AUC(INF) where the denominator is the AUC(INF) of the reference therapy, 10mg of Apixaban (whole tablet).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thrombosis']}, 'referencesModule': {'references': [{'pmid': '27292282', 'type': 'DERIVED', 'citation': 'Song Y, Chang M, Suzuki A, Frost RJ, Kelly A, LaCreta F, Frost C. Evaluation of Crushed Tablet for Oral Administration and the Effect of Food on Apixaban Pharmacokinetics in Healthy Adults. Clin Ther. 2016 Jul;38(7):1674-1685.e1. doi: 10.1016/j.clinthera.2016.05.004. Epub 2016 Jun 10.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the bioavailability of apixaban crushed tablets suspended in water or mixed with applesauce is similar to the bioavailability of apixaban whole tablets administered orally.', 'detailedDescription': 'This study will investigate the bioavailability of apixaban administered as crushed tablets suspended in water and as crushed tablets mixed with applesauce compared with that of whole tablets. The study results may allow enhancement of the apixaban label to include alternative methods of apixaban administration, which may be of benefit to patients who have difficulty swallowing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Healthy participants as determined by no clinically significant deviation from normal in findings of medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory tests.\n* Women of childbearing potential allowed. Must be following highly effective methods of contraception\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness\n* History of significant head injury within the last 2 years, including individuals with base of skull fractures\n* Any major surgery within 4 weeks of study drug administration or anticipated within 2 weeks after completion of the study\n* Any gastrointestinal (GI) surgery or GI disease that could impact absorption of study drug\n* History of Gilbert's Syndrome\n* Inability to tolerate oral medication\n* Inability to be venipunctured and/or tolerate venous access\n* Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to study drug administration\n* Any laboratory test results outside of the range of normal, confirmed by repeat results of:\n\n * Platelet count \\<150,000 cells/µL\n * Activated partial thromboplastin time \\>upper limit of normal (ULN)\n * International normalized ratio \\>ULN\n * Alanine aminotransferase \\>ULN\n * Aspartate aminotransferase \\>ULN\n * Total bilirubin \\>ULN\n * Serum creatinine ≥1.5 mg/dL\n * Hemoglobin \\<lower limit of normal (LLN)\n * Hematocrit \\<LLN"}, 'identificationModule': {'nctId': 'NCT02101112', 'briefTitle': 'Bioavailability of Apixaban Crushed Tablet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Relative Bioavailability of Crushed Apixaban Tablets Administered With Water or Apple Sauce Compared With Intact Tablet in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CV185-292'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apixaban, 10 mg (whole tablets)', 'description': 'Participants received a single dose of apixaban, 10 mg, given orally as 2 5-mg whole commercial tablets (reference)', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Apixaban, 10 mg (crushed and suspended in water)', 'description': 'Participants received a single dose of apixaban, 10 mg, given by mouth as 2 5-mg whole commercial tablets crushed and suspended in 30 mL of water', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Apixaban, 10 mg (crushed and mixed with applesauce)', 'description': 'Participants received a single dose of 10 mg, given by mouth as 2 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce', 'interventionNames': ['Drug: Apixaban']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'otherNames': ['Eliquis®'], 'armGroupLabels': ['Apixaban, 10 mg (crushed and mixed with applesauce)', 'Apixaban, 10 mg (crushed and suspended in water)', 'Apixaban, 10 mg (whole tablets)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}