Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT00926302
Status:
COMPLETED
Last Update Posted:
2009-06-23
First Post:
2009-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study of Levetiracetam Versus Keppra
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077287', 'term': 'Levetiracetam'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-22', 'studyFirstSubmitDate': '2009-06-18', 'studyFirstSubmitQcDate': '2009-06-22', 'lastUpdatePostDateStruct': {'date': '2009-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the bioequivalence', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['The bioequivalence of Levetiracetam vs. Keppra', 'volunteer'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra administered under fasting conditions to healthy adult subjects.', 'detailedDescription': 'This study is a randomized, single, two-way crossover pivotal study. The pharmacokinetic blood samples and vital signs were obtained before and after administration at scheduled intervals as indicated in the study protocol.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.\n2. Healthy adult male, aged between 20 and 40 years old.\n3. Body Mass Index between 18.5 and 25 (inclusive).\n4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.\n5. No significant deviation from normal biochemistry examination.\n6. No significant deviation from normal hematology examination.\n7. No significant deviation from normal urinalysis examination.\n\nExclusion Criteria:\n\n1. History of drug or alcohol abuse within the past year.\n2. Medical history of severe drug allergy or sensitivity to analogous drug.\n3. Evidence of acute or chronic disease or having undergone surgery from 4 weeks prior to Period I dosing.\n4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.\n5. Ongoing peptic ulcer and constipation.\n6. Planned vaccination during the time course of the study.\n7. Taking any clinical investigation drug from 2 months prior to Period I dosing.\n8. Use of any medication, including herb medicine or vitamins from 4 weeks before the study.\n9. Blood donation of more than 500 mL within the past 3 months.\n10. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result.\n11. A positive test for HIV antibody.'}, 'identificationModule': {'nctId': 'NCT00926302', 'briefTitle': 'A Bioequivalence Study of Levetiracetam Versus Keppra', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'A Randomized, Single, Two-Way Crossover Pivotal Study to Assess the Bioequivalence Study of Levetiracetam vs. Keppra Administered Under Fasting Conditions to Healthy Adult Subject', 'orgStudyIdInfo': {'id': 'MCPE08034M1'}, 'secondaryIdInfos': [{'id': 'TSGHIRB097-02-006'}, {'id': 'C159'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test drug', 'description': 'Levetiracetam one period', 'interventionNames': ['Drug: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference drug', 'description': 'Keppra one period', 'interventionNames': ['Drug: Keppra (Levetiracetam - USB SA Pharma Sector)']}], 'interventions': [{'name': 'Levetiracetam (Lotus Pharmaceutical Co.,Ltd.)', 'type': 'DRUG', 'otherNames': ['The test drug Levetiracetam is no brand name.', 'Manufacturer:Lotus Pharmaceutical Co.,Ltd.'], 'description': 'Levetiracetam 500mg/tablet Oral once', 'armGroupLabels': ['Test drug']}, {'name': 'Keppra (Levetiracetam - USB SA Pharma Sector)', 'type': 'DRUG', 'otherNames': ['Keppra', 'Manufracturer:USB SA Pharma Sector'], 'description': 'Levetiracetam 500mg/tablet oral once', 'armGroupLabels': ['Reference drug']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'I-Shin Shiah, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tri-Service General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'I-Shin Shiah/The Head of Department of Psychiatry', 'oldOrganization': 'Tri-Service General Hospital'}}}}