{ "FullStudy":{ "Rank":218027, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513681", "OrgStudyIdInfo":{ "OrgStudyId":"AAI-US-136" }, "Organization":{ "OrgFullName":"Dr. Reddy's Laboratories Limited", "OrgClass":"INDUSTRY" }, "BriefTitle":"Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition", "OfficialTitle":"Single Dose, Two-way, Crossover, Oral Bioequivalence Study of Lamotrigine Tablets 200 mg With Lamictal® Tablets 200 mg in Healthy, Volunteers Under Fed Condition." }, "StatusModule":{ "StatusVerifiedDate":"October 2002", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2002" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"November 2002", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2002", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 17, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 17, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 20, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Dr. Reddy's Laboratories Limited", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This is an single dose,two-way, crossover, oral bioequivalence study.", "DetailedDescription":"The study was an single dose, two-way, crossover, oral bioequivalence study of Lamotrigine tablets 200 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL® tablets 200 mg of GlaxoSmithKline Inc, in healthy, adult, human subjects under fed condition. 20 subjects (14 male and 6 womens) are enrolled and completed the study. The washout period is 14 days between the two periods of the study." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Healthy" ] }, "KeywordList":{ "Keyword":[ "Bioequivalence", "Lamotrigine", "crossover" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"20", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Lamotrigine Tablets 200 mg", "ArmGroupType":"Experimental", "ArmGroupDescription":"Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Lamotrigine", "Drug: Lamictal®" ] } },{ "ArmGroupLabel":"Lamictal® 200 mg Tablets", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Lamictal® 200 mg Tablets of GlaxoSmithKline Inc", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Lamotrigine", "Drug: Lamictal®" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Lamotrigine", "InterventionDescription":"Lamotrigine Tablets 200 mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Lamictal® 200 mg Tablets", "Lamotrigine Tablets 200 mg" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Lamictal® 200 mg" ] } },{ "InterventionType":"Drug", "InterventionName":"Lamictal®", "InterventionDescription":"Lamictal® 200 mg Tablets", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Lamictal® 200 mg Tablets", "Lamotrigine Tablets 200 mg" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Area under curve (AUC)", "PrimaryOutcomeTimeFrame":"Pre-dose 0.25, 0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,36,48,72,96,120 hours" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy males and females at least 18 years of age inclusive\nInformed of the nature of the study and given written informed consent\nHave a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs.\n\nExclusion Criteria:\n\nHypersensitivity to Lamotrigine (Lamictal®) or similar compounds or any history of seizures or clinically significant neurological conditions.\nAny history of a clinical condition which might affect drug absorption, metabolism or excretion\nRecent history of mental illness, drug addition,drug abuse or alcoholism\nDonation of greater than 500 ml of blood in the past 4 weeks prior to study dosing of difficulty in donating blood.\nReceived an investigational drug within the 4 weeks prior to study dosing.\nCurrently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the -counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutics indications as judged by the attending physician.\nTobacco use (>5 cigarettes per day) in the 3 months prior to study dosing.\nIf female, the subjects is lactating or has a positive pregnancy test screening and prior to each of the two treatments periods. Females of child bearing potential must use a medical acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods or contraception that may be used by the subject and/or her partner are; oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"44 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Dr. Ralph Scallion, MD", "OverallOfficialAffiliation":"AAI Clinic", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"AAI Clinic", "LocationCity":"Quadrangle drive", "LocationState":"North Carolina", "LocationZip":"27514", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000077213", "InterventionMeshTerm":"Lamotrigine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000927", "InterventionAncestorTerm":"Anticonvulsants" },{ "InterventionAncestorId":"D000002121", "InterventionAncestorTerm":"Calcium Channel Blockers" },{ "InterventionAncestorId":"D000049990", "InterventionAncestorTerm":"Membrane Transport Modulators" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000077264", "InterventionAncestorTerm":"Calcium-Regulating Hormones and Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000014150", "InterventionAncestorTerm":"Antipsychotic Agents" },{ "InterventionAncestorId":"D000014149", "InterventionAncestorTerm":"Tranquilizing Agents" },{ "InterventionAncestorId":"D000002492", "InterventionAncestorTerm":"Central Nervous System Depressants" },{ "InterventionAncestorId":"D000011619", "InterventionAncestorTerm":"Psychotropic Drugs" },{ "InterventionAncestorId":"D000026941", "InterventionAncestorTerm":"Sodium Channel Blockers" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M1701", "InterventionBrowseLeafName":"Lamotrigine", "InterventionBrowseLeafAsFound":"Lamictal", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2827", "InterventionBrowseLeafName":"Anticonvulsants", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3963", "InterventionBrowseLeafName":"Calcium", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3980", "InterventionBrowseLeafName":"Calcium, Dietary", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3966", "InterventionBrowseLeafName":"Calcium Channel Blockers", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15487", "InterventionBrowseLeafName":"Antipsychotic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M13057", "InterventionBrowseLeafName":"Psychotropic Drugs", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M28612", "InterventionBrowseLeafName":"Diuretics, Potassium Sparing", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M21761", "InterventionBrowseLeafName":"Sodium Channel Blockers", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ChanBlk", "InterventionBrowseBranchName":"Channel Blockers" },{ "InterventionBrowseBranchAbbrev":"AntiConv", "InterventionBrowseBranchName":"Anticonvulsants" },{ "InterventionBrowseBranchAbbrev":"CNSDep", "InterventionBrowseBranchName":"Central Nervous System Depressants" },{ "InterventionBrowseBranchAbbrev":"PsychDr", "InterventionBrowseBranchName":"Psychotropic Drugs" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"BDCA", "InterventionBrowseBranchName":"Bone Density Conservation Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000044342", "ConditionMeshTerm":"Malnutrition" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009748", "ConditionAncestorTerm":"Nutrition Disorders" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M23893", "ConditionBrowseLeafName":"Malnutrition", "ConditionBrowseLeafAsFound":"Under Fed", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M11267", "ConditionBrowseLeafName":"Nutrition Disorders", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }