Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT01618903
Status:
COMPLETED
Last Update Posted:
2012-08-03
First Post:
2012-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-02', 'studyFirstSubmitDate': '2012-06-11', 'studyFirstSubmitQcDate': '2012-06-11', 'lastUpdatePostDateStruct': {'date': '2012-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable concentration (AUC(0-t))', 'timeFrame': 'Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration'}, {'measure': 'Area under the plasma drug concentration-time curve from 0 to infinity (AUC)', 'timeFrame': 'Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration', 'description': 'The area under the curve extrapolated to infinity is calculated as the sum of AUC(0-t) and a residual part extrapolated to infinite time.'}, {'measure': 'Maximum measured plasma concentration (Cmax)', 'timeFrame': 'Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration', 'description': 'The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma drug concentration-time curve calculated from 0 to 12 h (AUC(0-12))', 'timeFrame': 'Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration'}, {'measure': "Plasma concentration at the end of the 45-minutes intravenous (iv) infusion (C45'(iv))", 'timeFrame': 'Pharmacokinetic samples were taken at 45 min after Levetiracetam administration', 'description': 'The value of the plasma concentration at the end of the 45-min iv infusion is directly obtained from the experimental data of plasma concentration versus time curves.'}, {'measure': 'Time to reach the maximum plasma concentration of Levetiracetam after administration (tmax)', 'timeFrame': 'Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration'}, {'measure': 'Terminal half-life of Levetiracetam (t1/2)', 'timeFrame': 'Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration', 'description': 'The terminal half-life associated with the terminal rate constant λ\\_z is calculated as: ln2/λ\\_z. λ\\_z is the first order rate constant of elimination.'}, {'measure': 'Total body clearance after intravenous infusion of Levetiracetam (CL(iv))', 'timeFrame': 'Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration', 'description': 'The CL(iv) is calculated as:\n\nCL=Dose of LEV/AUC.'}, {'measure': 'Apparent total body clearance after oral administration of Levetiracetam (CL/F(tablet))', 'timeFrame': 'Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration', 'description': 'The CL/F (tablet) is calculated as:\n\nCL/F=Dose of LEV/AUC.'}, {'measure': 'Volume of distribution after intravenous infusion of Levetiracetam (Vz(iv))', 'timeFrame': 'Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration', 'description': 'The volume of distribution after iv infusion is calculated as:\n\nVz=CL/λ\\_z, where CL is the total body clearance and λ\\_z the first order rate constant of elimination.'}, {'measure': 'Apparent volume of distribution after oral administration of Levetiracetam (Vz/F(tablet))', 'timeFrame': 'Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration', 'description': 'The apparent volume of distribution after oral administration is calculated as:\n\nVz/F= (CL/F)/λ\\_z.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Keppra Levetiracetam intravenous', 'Oral tablets', 'Bioequivalence', 'Pharmacokinetics', 'Safety', 'Chinese healthy volunteers'], 'conditions': ['Human Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The part A of N01362 is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to tablet oral administration in Chinese healthy volunteers.', 'detailedDescription': 'The study includes 2 parts, part A is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to oral tablet, part B is to assess pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chinese, age 18-40, weight ≥ 50 kg\n* Healthy volunteers with normal vital signs, good physical and mental health status and normal electrocardiogram and laboratory test\n\nExclusion Criteria:\n\n* History or presence of each systems disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication\n* History or presence of drug addiction or excessive use of alcohol\n* Symptomatic or asymptomatic Orthostatic Hypotension at screening\n* Current smokers and former smokers\n* Heavy caffeine drinker\n* History of frequent and severe headache\n* Any drug treatment\n* Subjects who are known to have Serum Hepatitis or who are carriers of the Hepatitis B surface antigen, or Hepatitis C antibody or who are HIV positive\n* Subjects on a controlled sodium diet\n* Subject has made a blood donation or had a comparable blood loss'}, 'identificationModule': {'nctId': 'NCT01618903', 'briefTitle': 'An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Monocenter, Open-label, Two-way Randomized Cross-over Study to Evaluate the Bioequivalence of Levetiracetam Administered as a 45 Minutes Intravenous Infusion and Same Dosage Levetiracetam Oral Tablet (Part A); and a Randomized, Double-blind, Placebo-controlled, Parallel Study on the Safety, Tolerability and Pharmacokinetics of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of b.i.d. Dosing (Part B), in Chinese Healthy Volunteers', 'orgStudyIdInfo': {'id': 'N01362A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levetiracetam iv infusion', 'description': 'Levetiracetam intravenous (iv) 45 min infusion administered as one single dose.', 'interventionNames': ['Drug: Levetiracetam']}, {'type': 'EXPERIMENTAL', 'label': 'Levetiracetam oral tablet', 'description': 'Levetiracetam oral tablet administered as one single dose.', 'interventionNames': ['Drug: Levetiracetam']}], 'interventions': [{'name': 'Levetiracetam', 'type': 'DRUG', 'otherNames': ['Keppra'], 'description': 'Levetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution in the morning of Day 1.', 'armGroupLabels': ['Levetiracetam iv infusion']}, {'name': 'Levetiracetam', 'type': 'DRUG', 'otherNames': ['Keppra'], 'description': 'Levetiracetam single oral administration of 3 tablets of 500 mg immediate release tablet.', 'armGroupLabels': ['Levetiracetam oral tablet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': '1', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}