Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT00960856
Status:
COMPLETED
Last Update Posted:
2009-10-20
First Post:
2009-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Four Arm Food Effect Study of Fenofibric Acid Tablets
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': 'clincialtrials@urlmutual.com', 'phone': '215-697-1743', 'title': 'Medical Director', 'organization': 'Mutual Pharmaceutical Company, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': '37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.', 'eventGroups': [{'id': 'EG000', 'title': 'Low-Fat Meal - Treatment A', 'description': 'Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.', 'otherNumAtRisk': 35, 'otherNumAffected': 9, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Meal - Treatment B', 'description': 'Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.', 'otherNumAtRisk': 36, 'otherNumAffected': 2, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High-fat, High-calorie Meal - Treatment C', 'description': 'Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.', 'otherNumAtRisk': 35, 'otherNumAffected': 4, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Fasted - Treatment D', 'description': 'Each subject received one tablet of 105 mg fenofibric acid following an overnight fast of at least 10 hours.', 'otherNumAtRisk': 35, 'otherNumAffected': 4, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel puncture site hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel puncture site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood creatine kinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-fat Meal - Treatment A', 'description': 'Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.'}, {'id': 'OG001', 'title': 'Standard Meal - Treatment B', 'description': 'Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.'}, {'id': 'OG002', 'title': 'High-Fat, High-Calorie Meal - Treatment C', 'description': 'Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.'}, {'id': 'OG003', 'title': 'Fasted - Treatment D', 'description': 'Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '9,806.74', 'spread': '2,120.78', 'groupId': 'OG000'}, {'value': '9,854.39', 'spread': '1,980.77', 'groupId': 'OG001'}, {'value': '7,950.75', 'spread': '1,920.85', 'groupId': 'OG002'}, {'value': '12,061.67', 'spread': '2,241.31', '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.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-fat Meal - Treatment A', 'description': 'Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.'}, {'id': 'OG001', 'title': 'Standard Meal - Treatment B', 'description': 'Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.'}, {'id': 'OG002', 'title': 'High-Fat, High-Calorie Meal - Treatment C', 'description': 'Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.'}, {'id': 'OG003', 'title': 'Fasted - Treatment D', 'description': 'Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '132,636.84', 'spread': '47,627.60', 'groupId': 'OG000'}, {'value': '134,928.11', 'spread': '50,262.64', 'groupId': 'OG001'}, {'value': '134,814.42', 'spread': '47,130.53', 'groupId': 'OG002'}, {'value': '139,975.28', 'spread': '48,821.99', '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.', 'unitOfMeasure': 'ng-hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.'}, {'type': 'PRIMARY', 'title': 'The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-fat Meal - Treatment A', 'description': 'Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.'}, {'id': 'OG001', 'title': 'Standard Meal - Treatment B', 'description': 'Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.'}, {'id': 'OG002', 'title': 'High-Fat, High-Calorie Meal - Treatment C', 'description': 'Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.'}, {'id': 'OG003', 'title': 'Fasted - Treatment D', 'description': 'Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '145,827.10', 'spread': '56,137.08', 'groupId': 'OG000'}, {'value': '148,367.21', 'spread': '58,828.43', 'groupId': 'OG001'}, {'value': '148,488.53', 'spread': '55,949.04', 'groupId': 'OG002'}, {'value': '152,571.61', 'spread': '55,060.83', '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.', 'unitOfMeasure': 'ng-hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence ABCD', 'description': 'Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.'}, {'id': 'FG001', 'title': 'Sequence BCDA', 'description': 'Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state'}, {'id': 'FG002', 'title': 'Sequence CDAB', 'description': 'Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state'}, {'id': 'FG003', 'title': 'Sequence DABC', 'description': 'Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.'}], 'periods': [{'title': 'Period I', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period of 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'comment': 'personal reasons', 'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period of 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period III', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout Period of 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period IV', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Non-obese, non-smoking, healthy adult volunteers consisting of members of the community-at-large were enrolled.', 'preAssignmentDetails': '88 subjects were screened and 51 were screen failures. Enrollment of 40 subjects was planned, however, the enrollment of 37 subjects was judged to be sufficient to meet the criterion of 36 necessary to complete the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Low-Fat Meal, Standard Meal, High Fat/High Calorie Meal,Fasted', 'description': 'All subjects received each of the four study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8, 15 and 22 each subject received one tablet of fenofibric acid 105 mg administered after one of the following meal conditions: 1) low-fat meal, 2) standard meal, 3) high-fat/high-calorie meal 4) overnight fast of at least 10 hours.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.89', 'spread': '6.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', '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': '1', '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': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '33', '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': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-16', 'studyFirstSubmitDate': '2009-08-14', 'resultsFirstSubmitDate': '2009-08-27', 'studyFirstSubmitQcDate': '2009-08-17', 'lastUpdatePostDateStruct': {'date': '2009-10-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-12', 'studyFirstPostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', '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.'}, {'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.'}, {'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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to characterize the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption. Additionally, the safety and tolerability of this dose and regimen of fenofibric acid will be evaluated.', 'detailedDescription': "The primary objective of this study is to determine the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption. Forty healthy, non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 45 years old will receive a single oral dose of fenofibric acid in one of four randomly assigned sequences of meal conditions each separated by a 7 day washout period. On study Days 1, 8, 15 and 22 each subject will receive a single oral dose (1 x 105 mg tablet) of fenofibric acid following an overnight fast of at least 10 hours or with a low-fat meal, standard meal, or high-fat/high-calorie meal according to their randomization sequence. Subjects will fast for at least 4.25 hours after dosing in each of the four dosing conditions. Blood samples will be drawn from all participants before dosing and for 72 hours post-dose at times sufficient to adequately define the pharmacokinetics of fenofibric acid. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Seated blood pressure and heart rate will be measured prior to dosing and at 2 hours post-dose. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported 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 between the ages of 18 and 45\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': 'NCT00960856', 'briefTitle': 'Four Arm Food Effect Study of Fenofibric Acid Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mutual Pharmaceutical Company, Inc.'}, 'officialTitle': 'A Four Arm, Single-Dose, Food Effect Evaluation With 105 mg Fenofibric Acid Tablets Administered in a Fasted State and Three Different Fed Conditions, Low-Fat/Low Calorie Meal, Standard Meal, and High-Fat/High Calorie Meal', 'orgStudyIdInfo': {'id': 'MPC-028-07-1009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fenofibric Acid 105 mg - Low-Fat Meal', 'description': 'Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.', 'interventionNames': ['Drug: Fenofibric Acid 105 mg Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Fenofibric Acid 105 mg - Standard Meal', 'description': 'Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a standard breakfast.', 'interventionNames': ['Drug: Fenofibric Acid 105 mg Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Fenofibric Acid 105 mg - High-Fat/High-Calorie Meal', 'description': 'Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.', 'interventionNames': ['Drug: Fenofibric Acid 105 mg Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Fenofibric Acid 105 mg - Fasted State', 'description': 'Fenofibric Acid 105 mg tablet administered after an overnight fast of at least 10 hours', 'interventionNames': ['Drug: Fenofibric Acid 105 mg Tablet']}], 'interventions': [{'name': 'Fenofibric Acid 105 mg Tablet', 'type': 'DRUG', 'description': 'One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.', 'armGroupLabels': ['Fenofibric Acid 105 mg - Low-Fat Meal']}, {'name': 'Fenofibric Acid 105 mg Tablet', 'type': 'DRUG', 'description': 'One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast', 'armGroupLabels': ['Fenofibric Acid 105 mg - Standard Meal']}, {'name': 'Fenofibric Acid 105 mg Tablet', 'type': 'DRUG', 'description': 'One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.', 'armGroupLabels': ['Fenofibric Acid 105 mg - High-Fat/High-Calorie Meal']}, {'name': 'Fenofibric Acid 105 mg Tablet', 'type': 'DRUG', 'description': 'One 105 mg tablet administered after an overnight fast of at least 10 hours.', 'armGroupLabels': ['Fenofibric Acid 105 mg - Fasted State']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'PRACS Institute, Ltd. - Cetero Research', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mutual Pharmaceutical Company, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Vice President, Branded Products and Medical Affairs', 'oldOrganization': 'Mutual Pharmaceutical Company, Inc.'}}}}