Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2025-12-27 @ 9:12 PM
Study NCT ID:
NCT00834561
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2009-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of 200 mg Lamotrigine Tablet Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
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'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Lamotrigine 200 mg Tablet (test) dosed in either period'}, {'id': 'OG001', 'title': 'Lamictal®', 'description': 'Lamictal® 200 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '2912.04', 'spread': '501.00', 'groupId': 'OG000'}, {'value': '2802.93', 'spread': '515.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Test/Ref Ratio of LS Means x 100', 'ciPctValue': '90', 'paramValue': '104.14', 'ciLowerLimit': '99.99', 'ciUpperLimit': '108.47', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 120 hour period', 'description': 'Bioequivalence based on Cmax', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-06'}, {'type': 'PRIMARY', 'title': 'AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Lamotrigine 200 mg Tablet (test) dosed in either period'}, {'id': 'OG001', 'title': 'Lamictal®', 'description': 'Lamictal® 200 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '139995.13', 'spread': '53706.28', 'groupId': 'OG000'}, {'value': '132859.81', 'spread': '44043.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Test/Ref Ratio of LS Means x 100', 'ciPctValue': '90', 'paramValue': '104.07', 'ciLowerLimit': '101.33', 'ciUpperLimit': '106.89', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 120 hour period', 'description': 'Bioequivalence based on AUC0-inf', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-06'}, {'type': 'PRIMARY', 'title': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lamotrigine', 'description': 'Lamotrigine 200 mg Tablet (test) dosed in either period'}, {'id': 'OG001', 'title': 'Lamictal®', 'description': 'Lamictal® 200 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '120080.26', 'spread': '33673.89', 'groupId': 'OG000'}, {'value': '115209.98', 'spread': '29212.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Test/Ref Ratio of LS Means x 100', 'ciPctValue': '90', 'paramValue': '103.68', 'ciLowerLimit': '101.42', 'ciUpperLimit': '106.00', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 120 hour period', 'description': 'Bioequivalence based on AUC0-t', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-06'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lamotrigine (Test) First', 'description': 'Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period'}, {'id': 'FG001', 'title': 'Lamictal® (Reference) First', 'description': 'Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lamotrigine (Test) First', 'description': 'Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period'}, {'id': 'BG001', 'title': 'Lamictal® (Reference) First', 'description': 'Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2002-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2009-01-30', 'resultsFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2009-01-30', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-06-30', 'studyFirstPostDateStruct': {'date': '2009-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Observed Concentration', 'timeFrame': 'Blood samples collected over 120 hour period', 'description': 'Bioequivalence based on Cmax'}, {'measure': 'AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'timeFrame': 'Blood samples collected over 120 hour period', 'description': 'Bioequivalence based on AUC0-inf'}, {'measure': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)', 'timeFrame': 'Blood samples collected over 120 hour period', 'description': 'Bioequivalence based on AUC0-t'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Healthy Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a bioequivalence study to compare the rate and extent of absorption of lamotrigine (test) and Lamictal® (reference)administered as a 1 x 200 mg tablet under fasting conditions.', 'detailedDescription': 'Criteria for Evaluation: FDA Bioequivalence Criteria\n\nStatistical Methods: FDA bioequivalence statistical methods'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Subjects will be females and/or males, non-smokers, 18 years of age and older.\n* Female Subjects will be post-menopausal or surgically sterilized.\n* Post-menopausal status is defined as absence of menses for the past 12 months,\n* Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.\n\nExclusion Criteria\n\nSubjects to whom any of the following applies will be excluded from the study:\n\n* Clinically significant illnesses within 4 weeks of the administration of study medication.\n* Clinically significant surgery within 4 weeks prior to the administration of the study medication.\n* Any clinically significant abnormality found during medical screening.\n* Subjects with a history of renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.\n* Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.\n* Abnormal laboratory tests judged clinically significant.\n* Positive urine drug screen at screening.\n* Positive testing for hepatitis B, hepatitis C or HIV at screening.\n* ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90; or heart rate less than 50 bpm) at screening.\n* Subjects with BMI ≥30.0.\n* History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).\n* History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.\n* Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subject's participation in this study.\n* History of allergic reactions to lamotrigine.\n* Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine, valproic acid, use of an investigational drug or participation on an investigation study within 30 days prior to the administration of the study medication.\n* Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products )including natural products, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.\n* Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.\n* Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows:\n* Less than 300 mL of whole blood within 30 days or\n* 300 mL to 500 mL of whole blood within 45 days or\n* more than 500 mL of whole blood within 56 days.\n* Positive alcohol breath test at screening.\n* Subjects who have used tobacco in any form within the 90 days preceding study drug administration.\n\nAdditional exclusion criteria for female subjects only:\n\n* Breast feeding subjects.\n* Positive urine pregnancy test at screening (performed on all females)."}, 'identificationModule': {'nctId': 'NCT00834561', 'briefTitle': 'Bioequivalence Study of 200 mg Lamotrigine Tablet Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Pharmaceuticals USA'}, 'officialTitle': 'Randomized, Two-Way Crossover, Single-Dose, Fasting Bioequivalence Study of Lamotrigine 1 x 200 mg Tablet', 'orgStudyIdInfo': {'id': '01305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lamotrigine', 'description': 'Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period', 'interventionNames': ['Drug: Lamotrigine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lamictal®', 'description': 'Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period', 'interventionNames': ['Drug: Lamictal®']}], 'interventions': [{'name': 'Lamotrigine', 'type': 'DRUG', 'description': '200 mg Tablet', 'armGroupLabels': ['Lamotrigine']}, {'name': 'Lamictal®', 'type': 'DRUG', 'description': '200 mg Tablet', 'armGroupLabels': ['Lamictal®']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 2K8', 'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Anapharm Inc.', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}], 'overallOfficials': [{'name': 'Benoit Girard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anapharm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Pharmaceuticals USA', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldOrganization': 'Teva Pharmaceuticals USA'}}}}