Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-27 @ 2:45 AM
Study NCT ID:
NCT01177293
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2010-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Amlodipine 10 mg Capsule', 'description': 'Single oral dose of amlodipine 10 mg capsule (Treatment A \\[Reference\\]).', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Amlodipine 10 mg ODT', 'description': 'Single oral dose of amlodipine 10 mg ODT (Treatment B \\[Test\\]).', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10 mg Capsule', 'description': 'Single oral dose of amlodipine 10 mg capsule (Treatment A \\[Reference\\]).'}, {'id': 'OG001', 'title': 'Amlodipine 10 mg ODT', 'description': 'Single oral dose of amlodipine 10 mg ODT (Treatment B \\[Test\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '401.655', 'groupId': 'OG000', 'lowerLimit': '61.74', 'upperLimit': '566.54'}, {'value': '360.619', 'groupId': 'OG001', 'lowerLimit': '266.76', 'upperLimit': '635.54'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric means ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.78', 'ciLowerLimit': '82.74', 'ciUpperLimit': '97.43', 'groupDescription': 'A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1155 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Natural log transformed AUC\\[0- ∞\\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours 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': 'hr*ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10 mg Capsule', 'description': 'Single oral dose of amlodipine 10 mg capsule (Treatment A \\[Reference\\]).'}, {'id': 'OG001', 'title': 'Amlodipine 10 mg ODT', 'description': 'Single oral dose of amlodipine 10 mg ODT (Treatment B \\[Test\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '331.300', 'groupId': 'OG000', 'lowerLimit': '60.42', 'upperLimit': '463.69'}, {'value': '330.394', 'groupId': 'OG001', 'lowerLimit': '243.87', 'upperLimit': '558.60'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.73', 'ciLowerLimit': '85.10', 'ciUpperLimit': '116.87', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose', 'description': 'Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized 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': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10 mg Capsule', 'description': 'Single oral dose of amlodipine 10 mg capsule (Treatment A \\[Reference\\]).'}, {'id': 'OG001', 'title': 'Amlodipine 10 mg ODT', 'description': 'Single oral dose of amlodipine 10 mg ODT (Treatment B \\[Test\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.427', 'groupId': 'OG000', 'lowerLimit': '1.88', 'upperLimit': '8.32'}, {'value': '5.571', 'groupId': 'OG001', 'lowerLimit': '3.92', 'upperLimit': '7.84'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric means ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '86.67', 'ciLowerLimit': '79.57', 'ciUpperLimit': '94.42', 'groupDescription': 'A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1278 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized 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': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10 mg Capsule', 'description': 'Single oral dose of amlodipine 10 mg capsule (Treatment A \\[Reference\\]).'}, {'id': 'OG001', 'title': 'Amlodipine 10 mg ODT', 'description': 'Single oral dose of amlodipine 10 mg ODT (Treatment B \\[Test\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '6.00', 'upperLimit': '14.00'}, {'value': '10.00', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '14.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized 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': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Amlodipine 10 mg Capsule', 'description': 'Single oral dose of amlodipine 10 mg capsule (Treatment A \\[Reference\\]).'}, {'id': 'OG001', 'title': 'Amlodipine 10 mg ODT', 'description': 'Single oral dose of amlodipine 10 mg ODT (Treatment B \\[Test\\]).'}], 'classes': [{'categories': [{'measurements': [{'value': '51.374', 'spread': '12.912', 'groupId': 'OG000'}, {'value': '45.120', 'spread': '4.921', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Amlodipine Capsule Then Amlodipine ODT', 'description': 'Single oral dose amlodipine besylate 10 mg capsule in first intervention period and single oral dose of amlodipine besylate 10 mg oral disintegrating tablet (ODT) in second intervention period. A washout period of 14 days was maintained between each period.'}, {'id': 'FG001', 'title': 'Amlodipine ODT Then Amlodipine Capsule', 'description': 'Single oral dose amlodipine besylate 10 mg ODT in first intervention period and single oral dose of amlodipine besylate 10 mg capsule in second intervention period. A washout period of 14 days was maintained between each period.'}], 'periods': [{'title': 'First Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period (of 14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes groups randomized to receive any treatment first (amlodipine capsule first and amlodipine ODT first).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.00', 'spread': '6.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2010-03-10', 'resultsFirstSubmitDate': '2011-06-28', 'studyFirstSubmitQcDate': '2010-08-05', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-08-01', 'studyFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours 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': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose', 'description': 'Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose'}, {'measure': 'Plasma Decay Half-life (t1/2)', 'timeFrame': '0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['biological availability', 'bioavailability', 'amlodipine', 'orally disintegrating tablet', 'ODT', 'tablets'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0531096&StudyName=Bioavailability%20Study%20Comparing%2010%20mg%20Amlodipine%20Besylate%20Orally%20Disintegrating%20Tablets%20%28ODT%29%20And%2010%20mg%20Amlodipine%20Besylate%20Capsules', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate capsule.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female literate subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).\n* Body Mass Index (BMI) of 17.5 to 26.4 kg/m2; and a total body weight \\>50 kg (110 lbs).\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* A positive urine drug screen.'}, 'identificationModule': {'nctId': 'NCT01177293', 'briefTitle': 'Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To 10 Mg Amlodipine Besylate Capsules, Manufactured By Pfizer France Under Fasted Conditions', 'orgStudyIdInfo': {'id': 'A0531096'}, 'secondaryIdInfos': [{'id': '052-10'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'treatment A - reference w/ water', 'interventionNames': ['Drug: Amlodipine - reference']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B - ODT (test) w/o water', 'interventionNames': ['Drug: Amlodipine ODT - test']}], 'interventions': [{'name': 'Amlodipine - reference', 'type': 'DRUG', 'description': 'Amlodipine capsule, 10 mg, single dose, with water', 'armGroupLabels': ['treatment A - reference w/ water']}, {'name': 'Amlodipine ODT - test', 'type': 'DRUG', 'description': 'Amlodipine orally disintegrating tablet (ODT), 10 mg, single dose, without water', 'armGroupLabels': ['Treatment B - ODT (test) w/o water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500 050', 'city': 'Hydrabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Pfizer Investigational Site'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Aurobindo Pharma Ltd', 'class': 'INDUSTRY'}, {'name': 'Trident Life Sciences Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}