Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT00839293
Status:
COMPLETED
Last Update Posted:
2010-10-15
First Post:
2009-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C533234', 'term': '2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid'}, {'id': 'C006012', 'term': 'fenofibric acid'}, {'id': 'D011345', 'term': 'Fenofibrate'}], 'ancestors': [{'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2010-10-14', 'studyFirstSubmitDate': '2009-02-06', 'studyFirstSubmitQcDate': '2009-02-06', 'lastUpdatePostDateStruct': {'date': '2010-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the bioavailability of ABT-335 in healthy subjects as measured by timed pharmacokinetic blood draws from pre-dose (0 hour) to 120 hours post dose', 'timeFrame': '14 Days'}, {'measure': 'To evaluate the safety and tolerability of ABT-335 in healthy adults after single dosage', 'timeFrame': '14 Days'}]}, 'conditionsModule': {'keywords': ['Bioavailability'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and compare the bioavailability of fenofibric acid from 2 different dosage strengths of ABT-335.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A condition of general good health\n* BMI 18 to 29\n\nExclusion Criteria:\n\n* Currently enrolled in another clinical study\n* Females who are pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT00839293', 'briefTitle': 'Comparison of Fenofibric Acid Bioavailability From ABT-335 Capsules', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Comparison of Fenofibric Acid Bioavailability From 45 mg and 135 mg Strength ABT-335 Capsules', 'orgStudyIdInfo': {'id': 'M10-788'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'ABT -335 capsules 135mg', 'interventionNames': ['Drug: ABT-335']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'ABT-335 capsules 45mg', 'interventionNames': ['Drug: ABT-335']}], 'interventions': [{'name': 'ABT-335', 'type': 'DRUG', 'otherNames': ['fenofibric acid', 'Trilipix'], 'description': 'Once, see arm description for more information', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60085', 'city': 'Waukegan', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 16862', 'geoPoint': {'lat': 42.36363, 'lon': -87.84479}}], 'overallOfficials': [{'name': 'Maureen Kelly, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Maureen Kelly, MD/Senior Medical Director', 'oldOrganization': 'Abbott'}}}}