Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT00681395
Status:
COMPLETED
Last Update Posted:
2012-09-28
First Post:
2008-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium
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': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'lastUpdateSubmitDate': '2012-09-27', 'studyFirstSubmitDate': '2008-05-19', 'studyFirstSubmitQcDate': '2008-05-19', 'lastUpdatePostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse event and safety laboratory assessments', 'timeFrame': '7 days'}, {'measure': 'Pharmacokinetic parameters', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adverse Events', 'Pharmacokinetic']}, 'descriptionModule': {'briefSummary': 'To evaluate safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General good health\n* BMI 19 to 29\n\nExclusion Criteria:\n\n* Currently enrolled in another study\n* Females who are pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00681395', 'briefTitle': 'Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'orgStudyIdInfo': {'id': 'M10-360'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'ABT-143 capsules 20/135 mg', 'interventionNames': ['Drug: ABT-143']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'ABT-335 135mg and rosuvastatin 20mg', 'interventionNames': ['Drug: ABT-335', 'Drug: Rosuvastatin']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'ABT-143 capsules 5/45mg', 'interventionNames': ['Drug: ABT-143']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'ABT-335 45mg and rosuvastatin 5mg', 'interventionNames': ['Drug: ABT-335', 'Drug: Rosuvastatin']}], 'interventions': [{'name': 'ABT-143', 'type': 'DRUG', 'description': 'once daily for 6 days', 'armGroupLabels': ['1', '3']}, {'name': 'ABT-335', 'type': 'DRUG', 'description': 'once daily for six days', 'armGroupLabels': ['2', '4']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'description': 'Once daily for 6 days', 'armGroupLabels': ['2', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 8089', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Torbjörn Lundström, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}