Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-29 @ 4:16 AM
Study NCT ID:
NCT00835666
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2009-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Finasteride 5 mg Tablets Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018120', 'term': 'Finasteride'}], 'ancestors': [{'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001378', 'term': 'Azasteroids'}, {'id': 'D013260', 'term': 'Steroids, Heterocyclic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialqueries@tevausa.com', 'phone': '1-866-384-5525', 'title': 'Manager, Biopharmaceutics', 'organization': 'Teva Pharmaceuticals USA'}, 'certainAgreement': {'otherDetails': 'Principal Investigator is not permitted to discuss or publish trial results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax - Maximum Observed Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Finasteride', 'description': 'Finasteride 5 mg Tablet (test) dosed in either period'}, {'id': 'OG001', 'title': 'Proscar®', 'description': 'Proscar® 5 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '35.550', 'spread': '10.170', 'groupId': 'OG000'}, {'value': '35.393', 'spread': '8.147', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Test/Ref Ratio x 100', 'ciPctValue': '90', 'paramValue': '98.5', 'ciLowerLimit': '92.6', 'ciUpperLimit': '105', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 36 hour period', 'description': 'Bioequivalence based on Cmax', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-06'}, {'type': 'PRIMARY', 'title': 'AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Finasteride', 'description': 'Finasteride 5 mg Tablet (test) dosed in either period'}, {'id': 'OG001', 'title': 'Proscar®', 'description': 'Proscar® 5 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '252.848', 'spread': '97.525', 'groupId': 'OG000'}, {'value': '256.783', 'spread': '94.167', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Test/Ref Ratio x 100', 'ciPctValue': '90', 'paramValue': '98.2', 'ciLowerLimit': '94.7', 'ciUpperLimit': '102', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 36 hour period', 'description': 'Bioequivalence based on AUCinf', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-06'}, {'type': 'PRIMARY', 'title': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Finasteride', 'description': 'Finasteride 5 mg Tablet (test) dosed in either period'}, {'id': 'OG001', 'title': 'Proscar®', 'description': 'Proscar® 5 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '247.327', 'spread': '90.563', 'groupId': 'OG000'}, {'value': '250.822', 'spread': '87.883', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Test/Ref Ratio x 100', 'ciPctValue': '90', 'paramValue': '98.4', 'ciLowerLimit': '94.9', 'ciUpperLimit': '102', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 36 hour period', 'description': 'Bioequivalence based on AUC0-t', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-06'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Finasteride (Test) First', 'description': 'Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period'}, {'id': 'FG001', 'title': 'Proscar® (Reference) First', 'description': 'Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Finasteride (Test) First', 'description': 'Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period'}, {'id': 'BG001', 'title': 'Proscar® (Reference) First', 'description': 'Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2009-02-03', 'resultsFirstSubmitDate': '2009-06-22', 'studyFirstSubmitQcDate': '2009-02-03', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-06-22', 'studyFirstPostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Observed Concentration', 'timeFrame': 'Blood samples collected over 36 hour period', 'description': 'Bioequivalence based on Cmax'}, {'measure': 'AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'timeFrame': 'Blood samples collected over 36 hour period', 'description': 'Bioequivalence based on AUCinf'}, {'measure': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)', 'timeFrame': 'Blood samples collected over 36 hour period', 'description': 'Bioequivalence based on AUC0-t'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Healthy Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the relative bioavailability of finasteride 5 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of PROSCAR® 5 mg tablets (Merck) in healthy, adult, non-smoking, male subjects under fasting conditions.', 'detailedDescription': 'Criteria for Evaluation: FDA Bioequivalence Criteria\n\nStatistical Methods: FDA bioequivalence statistical methods'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All subjects selected for this study will be male non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less.\n* Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.\n\nAdequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.\n\nClinical laboratory measurements will include the following:\n\n* Hematology: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count (with differential).\n* Clinical Chemistry: creatinine, BUN, glucose, SGOT/AST, SGPT/ALT, bilirubin, and alkaline phosphatase.\n* Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells.\n* HIV Screen: pre-study\n* Hepatitis B, C Screen: pre-study\n* Drugs of Abuse Screen: pre-study and at each check-in Subjects will be selected if all above are normal. Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.\n\nExclusion Criteria:\n\n* Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.\n* Subjects whose clinical laboratory test values are greater than 20% outside the normal range on retesting, the subject will not be significant.\n* Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.\n* All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each study period check-in. subjects found to have urin concentrations of any of the tested drugs will not be allowed to participate.\n* Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.\n* Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.\n* Subjects who do not tolerate venipuncture will not be allowed to participate.\n* Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is require.\n* Females will not be eligible to participate in the study."}, 'identificationModule': {'nctId': 'NCT00835666', 'briefTitle': 'Finasteride 5 mg Tablets Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Pharmaceuticals USA'}, 'officialTitle': 'A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'B026535'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Finasteride', 'description': 'Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period', 'interventionNames': ['Drug: Finasteride 5 mg tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Proscar®', 'description': 'Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period', 'interventionNames': ['Drug: PROSCAR®']}], 'interventions': [{'name': 'Finasteride 5 mg tablets', 'type': 'DRUG', 'description': '1 x 5 mg, single dose fasting', 'armGroupLabels': ['Finasteride']}, {'name': 'PROSCAR®', 'type': 'DRUG', 'description': '1 x 5 mg, single dose fasting', 'armGroupLabels': ['Proscar®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77042', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Novum Pharmaceutical Research Services', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'So Ran Hong, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novum Pharmaceutical Research Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Pharmaceuticals USA', 'class': 'INDUSTRY'}}}}