Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-04-26 @ 3:33 AM
Study NCT ID:
NCT02991261
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2016-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of SPARC001 (Study 2) 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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2016-12-08', 'studyFirstSubmitQcDate': '2016-12-08', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': '48 hours'}, {'measure': 'Cmax', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Adverse event', 'timeFrame': '25 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to determine the relative bioavailability, safety and tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult, male and female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit\n2. Body mass index (BMI) ≥18 to ≤30 kg/m2 and total body weight \\>50 kg (110 lbs) at Screening\n3. All female subjects must have a negative serum pregnancy test at Screening and at each Check-in Visit\n4. Medically healthy on the basis of medical history and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), as determined by the Investigator at Screening and each Check-In Visit.\n\nExclusion Criteria:\n\n1. Females who are pregnant, lactating, or likely to become pregnant during the study\n2. Life-time history and/or recent evidence of alcohol or drug/substance abuse disorder\n3. Subjects who need to maintain mental alertness throughout the study\n4. Subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results'}, 'identificationModule': {'nctId': 'NCT02991261', 'briefTitle': 'Bioavailability Study of SPARC001 (Study 2) in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharma Advanced Research Company Limited'}, 'officialTitle': 'A Randomized, Open-Label, Single-Dose Bioavailability Study of SPARC001in Healthy, Adult Volunteers Under Fed and Fasted Conditions"', 'orgStudyIdInfo': {'id': 'CLR_16_29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPARC001 type I', 'description': 'Treatment type I', 'interventionNames': ['Drug: SPARC001 type I', 'Drug: SPARC001 type II', 'Drug: Reference001 type I', 'Drug: Reference001 type II']}, {'type': 'EXPERIMENTAL', 'label': 'SPARC001 type II', 'description': 'Treatment type II', 'interventionNames': ['Drug: SPARC001 type I', 'Drug: SPARC001 type II', 'Drug: Reference001 type I', 'Drug: Reference001 type II']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference001 type I', 'description': 'Hydrocodone-Acetaminophen', 'interventionNames': ['Drug: SPARC001 type I', 'Drug: SPARC001 type II', 'Drug: Reference001 type I', 'Drug: Reference001 type II']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference type II', 'description': 'Hydrocodone-Acetaminophen', 'interventionNames': ['Drug: SPARC001 type I', 'Drug: SPARC001 type II', 'Drug: Reference001 type I', 'Drug: Reference001 type II']}], 'interventions': [{'name': 'SPARC001 type I', 'type': 'DRUG', 'description': 'Treatment type I', 'armGroupLabels': ['Reference type II', 'Reference001 type I', 'SPARC001 type I', 'SPARC001 type II']}, {'name': 'SPARC001 type II', 'type': 'DRUG', 'description': 'Treatment type II', 'armGroupLabels': ['Reference type II', 'Reference001 type I', 'SPARC001 type I', 'SPARC001 type II']}, {'name': 'Reference001 type I', 'type': 'DRUG', 'description': 'Hydrocodone-acetaminophen', 'armGroupLabels': ['Reference type II', 'Reference001 type I', 'SPARC001 type I', 'SPARC001 type II']}, {'name': 'Reference001 type II', 'type': 'DRUG', 'description': 'Hydrocodone Acetaminophen', 'armGroupLabels': ['Reference type II', 'Reference001 type I', 'SPARC001 type I', 'SPARC001 type II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07094', 'city': 'Secaucus', 'state': 'New Jersey', 'country': 'United States', 'facility': 'SPARC Site 01', 'geoPoint': {'lat': 40.78955, 'lon': -74.05653}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharma Advanced Research Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}