Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-28 @ 2:50 AM
Study NCT ID:
NCT02618395
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2015-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of SPARC001 in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma hydrocodone and acetaminophen concentration (Cmax)', 'timeFrame': '17 days'}], 'secondaryOutcomes': [{'measure': 'AUC extrapolated to infinity (AUC0 ∞)', 'timeFrame': '17 days'}, {'measure': 'Time to Cmax (tmax)', 'timeFrame': '17 days'}, {'measure': 'Elimination half-life (t½)', 'timeFrame': '17 days'}, {'measure': 'Treatment emergent adverse event', 'timeFrame': '17 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Bioavailability study', 'detailedDescription': 'Bioavailability, safety and tolerability'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult, male and female volunteers, 18 to 55 years of age\n* Body mass index (BMI) ≥18 to ≤30 kg/m2 at screening\n* Female subjects must have a negative serum pregnancy test\n* Medically healthy on the basis of medical history and physical examination\n\nExclusion Criteria:\n\n* Females who are pregnant, lactating, or likely to become pregnant during the study\n* Life-time history and/or recent evidence of alcohol\n* History of hypersensitivity to hydrocodone, acetaminophen or any component of the test and reference formulations\n* Subjects with any condition in which an opioid is contraindicated'}, 'identificationModule': {'nctId': 'NCT02618395', 'briefTitle': 'Bioavailability Study of SPARC001 in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharma Advanced Research Company Limited'}, 'orgStudyIdInfo': {'id': 'SUN-HBA-PK001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'interventionNames': ['Drug: SPARC001A']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'interventionNames': ['Drug: SPARC001B']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'interventionNames': ['Drug: Reference001 - Hydrocodone']}], 'interventions': [{'name': 'SPARC001A', 'type': 'DRUG', 'armGroupLabels': ['Treatment A']}, {'name': 'SPARC001B', 'type': 'DRUG', 'armGroupLabels': ['Treatment B']}, {'name': 'Reference001 - Hydrocodone', 'type': 'DRUG', 'description': 'Hydrocodone-acetaminophen', 'armGroupLabels': ['Treatment C']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharma Advanced Research Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}