Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-04-25 @ 12:00 AM
Study NCT ID:
NCT02713802
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2016-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Bioequivalence of Cudafol(R) and Diprivan(R) Administered as Single Intravenous Doses in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2016-01-15', 'studyFirstSubmitQcDate': '2016-03-15', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence based on pharmacokinetic parameter: Area Under Curve', 'timeFrame': '0-24 hours post dose'}, {'measure': 'Bioequivalence based on pharmacokinetic parameter: Cmax', 'timeFrame': '0-24 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameter: Tmax', 'timeFrame': '0-24 hours post dose'}, {'measure': 'Incidence of adverse events and tolerability', 'timeFrame': '7 days post dose', 'description': 'Number of adverse events and local tolerability'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single doses of Cudafol(R) and Diprivan(R) in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-obese men and women, 18 to 55 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Females of child-bearing potential must be using an approved contraceptive method.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant disease.\n* History or presence of clinically significant abnormal 12-lead electrocardiogram (ECG), blood pressure, or heart rate.\n* Pregnant or nursing (lactating) women.\n* Known hypersensitivity or allergy to propofol (or components of either formulation, including eggs, soybean oil or betadex sulfobutyl ether sodium) or any other forms of anesthesia, or has had a reaction to anesthesia in the past.\n* Family history of malignant hyperthermia.\n* History of drug or alcohol abuse (or tests positive at screening) or current smoker.\n* Poor venous access in either arm.\n* Tests positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody.\n\nOther protocol defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02713802', 'briefTitle': 'Pilot Study of Bioequivalence of Cudafol(R) and Diprivan(R) Administered as Single Intravenous Doses in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cuda Anesthetics, LLC'}, 'officialTitle': 'An Open-Label, Randomized, Two-Way Crossover Pilot Study of the Bioequivalence of Cudafol(R) and Diprivan(R) IV Administered as Single Intravenous Doses in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CUDA-C2015-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test product', 'description': 'Propofol solution (1% \\[10 mg/mL\\]), via intravenous injection', 'interventionNames': ['Drug: Cudafol(R) (propofol, 1% [10 mg/mL])']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference product', 'description': 'Propofol emulsion (1% \\[10 mg/mL\\]), via intravenous injection', 'interventionNames': ['Drug: Diprivan(R) (propofol, 1% [10 mg/mL])']}], 'interventions': [{'name': 'Cudafol(R) (propofol, 1% [10 mg/mL])', 'type': 'DRUG', 'description': 'Test product Cudafol(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes', 'armGroupLabels': ['Test product']}, {'name': 'Diprivan(R) (propofol, 1% [10 mg/mL])', 'type': 'DRUG', 'description': 'Reference product Diprivan(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes', 'armGroupLabels': ['Reference product']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cuda Anesthetics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}