Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-04-15 @ 4:21 PM
Study NCT ID:
NCT00961259
Status:
COMPLETED
Last Update Posted:
2012-06-08
First Post:
2009-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C006012', 'term': 'fenofibric acid'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@urlmutual.com', 'phone': '215-697-1743', 'title': 'Medical Director', 'organization': 'Mutual Pharmaceutical Company, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': '54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).', 'eventGroups': [{'id': 'EG000', 'title': 'Fenofibric Acid 35 mg (1 x 35 mg Tablet), Treatment A', 'description': 'Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 53, 'otherNumAffected': 7, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fenofibric Acid 105 mg (3 x 35 mg Tablet), Treatment B', 'description': 'Each subject received three (3) tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 54, 'otherNumAffected': 4, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Fenofibric Acid 105 mg (1 x 105 mg Tablet), Treatment C', 'description': 'Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.', 'otherNumAtRisk': 53, 'otherNumAffected': 5, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel puncture site hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Orthodontic appliance complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A', 'description': 'Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)', 'description': 'Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B', 'description': 'Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C', 'description': 'Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '3,569.47', 'spread': '685.12', 'groupId': 'OG000'}, {'value': '10,708.40', 'spread': '2,055.36', 'groupId': 'OG001'}, {'value': '11,014.93', 'spread': '2,033.94', 'groupId': 'OG002'}, {'value': '11,202.87', 'spread': '2,470.61', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration', 'description': 'The maximum or peak concentration that the drug reaches in the plasma. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the Cmax values were dose-adjusted in order to assess pharmacokinetic linearity.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A', 'description': 'Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)', 'description': 'Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B', 'description': 'Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C', 'description': 'Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '49,419.89', 'spread': '18,188.17', 'groupId': 'OG000'}, {'value': '148,259.66', 'spread': '54,564.52', 'groupId': 'OG001'}, {'value': '131,976.95', 'spread': '41,086.74', 'groupId': 'OG002'}, {'value': '135,119.10', 'spread': '42,326.25', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration', 'description': 'The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the \\[AUC(0-t)\\] values were dose-adjusted in order to assess pharmacokinetic linearity.', 'unitOfMeasure': 'ng-hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A', 'description': 'Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.'}, {'id': 'OG001', 'title': 'Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)', 'description': 'Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.'}, {'id': 'OG002', 'title': 'Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B', 'description': 'Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.'}, {'id': 'OG003', 'title': 'Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C', 'description': 'Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '58,304.35', 'spread': '20,877.56', 'groupId': 'OG000'}, {'value': '174,913.04', 'spread': '62,632.68', 'groupId': 'OG001'}, {'value': '142,858.88', 'spread': '45,554.44', 'groupId': 'OG002'}, {'value': '147,555.58', 'spread': '48,994.99', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.', 'description': 'The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the AUC(0-∞) values were dose-adjusted in order to assess pharmacokinetic linearity.', 'unitOfMeasure': 'ng-hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analyses of fenofibric acid are based on 53 out of the 54 subjects who completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Sequence ABC', 'description': 'On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (treatment B). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C).'}, {'id': 'FG001', 'title': 'Treatment Sequence BCA', 'description': 'On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A).'}, {'id': 'FG002', 'title': 'Treatment Sequence CAB', 'description': 'On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B).'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Washout Period of 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'comment': 'dropped due to concomitant medication used prior to admission.', 'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'due to concomitant medication used', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Washout Period of 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Fifty-Four (54) non-obese, non-smoking, healthy adult volunteers from the community at large were enrolled.', 'preAssignmentDetails': 'One hundred and eight (108) subjects were screened. Thirty-six (36) subjects were screen failures. Of the remaining seventy-two (72) subjects, fifty-six (56) checked in and fifty-four (54) were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fenofibric Acid - Treatments A, B and C', 'description': 'All subjects received each of the three study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8 and 15 each subject received either one 35 mg fenofibric acid tablet (treatment A), three 35 mg fenofibric acid tablets (105 mg total dose, treatment B) or one 105 mg fenofibric acid tablet (treatment C).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.46', 'spread': '7.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-01', 'studyFirstSubmitDate': '2009-08-14', 'resultsFirstSubmitDate': '2009-08-20', 'studyFirstSubmitQcDate': '2009-08-17', 'lastUpdatePostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-20', 'studyFirstPostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': 'serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration', 'description': 'The maximum or peak concentration that the drug reaches in the plasma. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the Cmax values were dose-adjusted in order to assess pharmacokinetic linearity.'}, {'measure': 'Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]', 'timeFrame': 'serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration', 'description': 'The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the \\[AUC(0-t)\\] values were dose-adjusted in order to assess pharmacokinetic linearity.'}, {'measure': 'The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)', 'timeFrame': 'serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.', 'description': 'The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant. For the dosing group, Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg), the AUC(0-∞) values were dose-adjusted in order to assess pharmacokinetic linearity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['healthy', 'pharmacokinetics', 'therapeutic equivalency', 'fenofibric acid'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each dose is administered under fasted conditions. Safety and tolerability of these regimens will also be evaluated.', 'detailedDescription': "This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each dose is administered under fasted conditions. Fifty-four healthy, non-smoking, non-obese, 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive each of three fenofibric acid dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of the first day of each dosing period, after an overnight fast of at least 10 hours, subjects will receive single doses of fenofibric acid (1 x 35 mg tablet), fenofibric acid (3 x 35 mg tablets - 105 mg total dose), or fenofibric acid (1 x 105 mg tablet). Fasting will continue for 4 hours after dose administration. Blood samples will be drawn from all participants prior to dosing and for 72 hours post-dose, at times sufficient to adequately define fenofibric acid pharmacokinetics. Subjects will be monitored throughout their participation for adverse reactions to the study drug and/or procedures. Seated blood pressure and pulse will be measured prior to each dose and approximately 2 hours after each dose to coincide with peak plasma concentrations. All adverse experiences, whether elicited by query, spontaneously reported, or observed by clinic staff, will be documented in the subject's case report form."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults 18-45 years of age\n* Non-smoking\n* Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures)\n* Body mass index (BMI) less than 30\n* Medically healthy on the basis of medical history and physical examination\n* Hemoglobin \\> or = to 12g/dL\n* Completion of the screening process within 28 days prior to dosing\n* Provision of voluntary written informed consent\n\nExclusion Criteria:\n\n* Recent participation (within 28 days) in other research studies\n* Recent significant blood donation or plasma donation\n* Pregnant or lactating\n* Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)\n* Recent (2-year) history or evidence of alcoholism or drug abuse\n* History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease\n* Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study\n* Drug allergies to fenofibric acid'}, 'identificationModule': {'nctId': 'NCT00961259', 'briefTitle': 'Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mutual Pharmaceutical Company, Inc.'}, 'officialTitle': 'Open-Label, Randomized, Single-Dose, 3-Arm, Crossover Pharmacokinetic and Bioequivalence Study of One 35 mg Fenofibric Acid Tablet and Three 35 mg Fenofibric Acid Tablets Versus One 105 mg Fenofibric Acid Tablet Under Fasting Conditions', 'orgStudyIdInfo': {'id': 'MPC-028-08-1017'}, 'secondaryIdInfos': [{'id': 'R08-0057'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fenofibric Acid 35 mg (1 x 35 mg tab)', 'description': '1 x 35 mg tablet administered after an overnight fast of at least 10 hours', 'interventionNames': ['Drug: Fenofibric Acid 35 mg Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Fenofibric Acid 105 mg (3 x 35 mg tab)', 'description': '3 x 35 mg tablets administered after an overnight fast of at least 10 hours', 'interventionNames': ['Drug: Fenofibric Acid 35 mg Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Fenofibric Acid 105 mg (1 x 105 mg tab)', 'description': '1 x 105 mg tablet administered after an overnight fast of at least 10 hours', 'interventionNames': ['Drug: Fenofibric Acid 105 mg Tablet']}], 'interventions': [{'name': 'Fenofibric Acid 35 mg Tablet', 'type': 'DRUG', 'description': '1 x 35 mg tablet administered after an overnight fast of at least 10 hours', 'armGroupLabels': ['Fenofibric Acid 35 mg (1 x 35 mg tab)']}, {'name': 'Fenofibric Acid 35 mg Tablet', 'type': 'DRUG', 'description': '3 x 35 mg tablets administered after an overnight fast of at least 10 hours', 'armGroupLabels': ['Fenofibric Acid 105 mg (3 x 35 mg tab)']}, {'name': 'Fenofibric Acid 105 mg Tablet', 'type': 'DRUG', 'description': '105 mg tablet administered after an overnight fast of at least 10 hours', 'armGroupLabels': ['Fenofibric Acid 105 mg (1 x 105 mg tab)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anthony R Godfrey, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PRACS Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mutual Pharmaceutical Company, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}