Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT06254235
Status:
COMPLETED
Last Update Posted:
2024-02-12
First Post:
2024-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy 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': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-03', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-02-03', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-28d', 'timeFrame': 'Day 0-28', 'description': 'The area under the concentration-time curve from dosing to Day 28'}, {'measure': 'AUC28-56d', 'timeFrame': 'Day 28-56', 'description': 'The area under the concentration-time curve from Day 28 to Day 56'}, {'measure': 'AUC0-t', 'timeFrame': 'Day 0-82', 'description': 'The area under the concentration-time curve from dosing to the last quantifiable time-point'}, {'measure': 'AUC0-∞', 'timeFrame': 'Day 0-82', 'description': 'The area under the concentration-time curve extrapolated to infinity'}, {'measure': 'Cmax', 'timeFrame': 'Day 0-82', 'description': 'The maximum drug concentration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers.\n\nParticipants will receive single-dose of either test or reference octreotide microsphere formulations.\n\nResearchers will compare pharmacokinetic characteristics of the two formulations to see if they are bioequivalent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 19-28 kg/m\\^2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female\n* In good physical condition (without any history of disease or clinically relevantly abnormal vital sign or examination\n* Agreed to use adequate contraception and did not plan for pregnancy from screening period throughout 6 months after study completion\n* Fully understood and voluntarily signed the informed consent form\n* With high compliance\n\nExclusion Criteria:\n\n* With allergic disease or allergic to any component of the study drugs or more than two kinds of other drug, food, or beverage\n* Positive for human immunodeficiency virus, hepatitis B, C, or syphilis test\n* With gastrointestinal disease\n* Had drug addiction within 5 years or used narcotics within 6 months before screening or positive in drug of abuse test\n* With alcohol consumption \\> 2 units/d within 6 months before screening\n* With cigarette consumption \\> 5/d within 3 months before screening\n* Donated or lost blood \\> 400 mL within 3 months before screening\n* Hospitalized or received surgery within 3 months before screening\n* Received study drug of other clinical trial within 3 months before screening\n* Received prescription drug within 14d before dosing\n* Received over-the-counter drug or herb within 48h before dosing\n* Consumed grape fruit juice, or other food or beverage containing caffeine or xanthine within 72h before dosing\n* Consumed alcohol within 48h before dosing or positive for breath alcohol test\n* Cannot consume standard meal\n* Intolerable to venipuncture\n* Cannot receive intramuscular injection in the glute\n* With vitamin B12 deficiency\n* Had acute minor disease (common cold, diarrhea, etc.) from screening to dosing\n* For pregnancy-capable female, breastfeeding or positive for pregnancy test at screening, or had unprotected sexual contact within 2 weeks before dosing\n* Other reason judged by investigators'}, 'identificationModule': {'nctId': 'NCT06254235', 'briefTitle': 'Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Bioequivalence Study of Octreotide Acetate Microsphere Injection in Human', 'orgStudyIdInfo': {'id': 'QL-YXZ2-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'interventionNames': ['Drug: The test octreotide microsphere']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference', 'interventionNames': ['Drug: The reference octreotide microsphere']}], 'interventions': [{'name': 'The test octreotide microsphere', 'type': 'DRUG', 'description': 'A single intramuscular dose of the test octreotide microsphere 30mg,', 'armGroupLabels': ['Test']}, {'name': 'The reference octreotide microsphere', 'type': 'DRUG', 'description': 'A single intramuscular dose of the reference octreotide microsphere 30mg', 'armGroupLabels': ['Reference']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266003', 'city': 'Qingdao', 'state': 'Shandong', 'country': 'China', 'facility': 'The Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}