{ "FullStudy":{ "Rank":218121, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512459", "OrgStudyIdInfo":{ "OrgStudyId":"610/06" }, "Organization":{ "OrgFullName":"Dr. Reddy's Laboratories Limited", "OrgClass":"INDUSTRY" }, "BriefTitle":"Bioavailability Study of Venlafaxine MR Capsules 150 mg Under Fed Conditions", "OfficialTitle":"An Open Label, Balanced, Randomized, Two-treatment, Two-sequence Two-period, Single Dose Sprinkled on Apple Sauce, Crossover and Relative Bioavailability Study in Healthy Adult, Human Subjects Under Fed Conditions" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2006" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2006", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2006", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 18, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 19, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Dr. Reddy's Laboratories Limited", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The objective of this study was to compare the relative bioavailability of Venlafaxine MR Capsules 150 mg with Effexor XR Capsules 150 mg under Fed conditions in healthy adult human subjects.", "DetailedDescription":"An open labeL balanced, randomized, two-treatment. two-period, two-sequence, single dose,crossover, evaluation of relative bioavailability of Venlafaxine 150 mg (as the HCl salt)MR capsules of Dr. Reddy's comparing with that of Effexor XR (containing Venlafaxine 150 mg (as the HCl salt)capsules of wyeth Laboratories, Philadelphia, PA, USA in healthy human subjects under fed conditions." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Healthy" ] }, "KeywordList":{ "Keyword":[ "Bioavailability", "Venlafaxine", "two way crossover" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"33", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Venlafaxine MR Capsules 150", "ArmGroupType":"Experimental", "ArmGroupDescription":"Venlafaxine MR Capsules 150 of Dr.Reddy's Laboratories Limited", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Venlafaxine" ] } },{ "ArmGroupLabel":"Effexor XR 150 mg Capsules", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Effexor XR 150 mg Capsules of Wyeth Laboratories Philadelphia, PA, USA", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Venlafaxine" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Venlafaxine", "InterventionDescription":"Venlafaxine MR Capsules 150 mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Effexor XR 150 mg Capsules", "Venlafaxine MR Capsules 150" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Effexor XR" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Area Under Curve (AUC)", "PrimaryOutcomeTimeFrame":"predose, 1.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 14.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects must fulfill all of the following criteria to be considered for inclusion into this study:\n\nSubjects who will provide written informed consent.\nSubjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.\nHaving a Body mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2\nSubjects must be of normal health as determined by medical history and physical examination performed within 21days prior to the commencement of the study.\nSubjects whose screening laboratory values are within normal limits or considered by the physician/investigator to be of no clinical significance.\nHave normal ECG, X-ray and vital signs.\nAvailability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidence by written informed consent.\n\nExclusion Criteria:\n\nSubjects incapable of understanding the informed consent.\n\nSubjects who have:\n\nSystolic blood pressure less than 90 mm of Hg and more than 140 .mm of Hg\nDiastolic blood pressure less than 60 mm of Hg and more than 94 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician/investigator.\nPulse rate below 50/min and above 100/min.\nHistory of hypersensitivity or idiosyncratic reaction to Venlafaxine or any other related drugs.\nAny evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal .function.\nConsumption of grapefruit for the past ten days prior to the dosing day until the completion of the study.\nRegular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking from 48 hours before dosing and until the completion of the study.\nSubjects who have taken over the counter or prescribed medications for during the last 7 days from the date of study.\nSubjects who have taken enzyme modifying drugs or any systemic medication within the past 30 days prior to start of clinical study\nHistory of any psychiatric illness, which may impair the ability to provide written, informed consent.\nSubjects with clinically significant abnormal values of laboratory parameters.\nSubjects who have participated in any other clinical investigation using experimental drug or had bled more than 330 mL in the past 90 days before the date of start of study.\nSubjects with positive screen for drugs of abuse and alcohol.\nAny subject in whom Venlafaxine is contraindicated for medical reasons.\nAny subject with recent history of surgery\nA history of difficulty in donating blood.\nA positive test result for HIV antibody and/or syphilis\nA recent history of alcoholism (< 2 years) or of moderate (180 ml/day) alcohol use, or consumption of alcohol within 48 hr prior to receiving Investigational Product.\nFemale subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study will not be allowed to participate.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"45 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Mohanlal Siva Prasad Sayana, Dr.", "OverallOfficialAffiliation":"Bioserve Clinical Research (P) Ltd", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Bioserve Clinical Research (P) Ltd", "LocationCity":"Balanagar", "LocationState":"Hyderabad", "LocationZip":"500 037", "LocationCountry":"India" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000069470", "InterventionMeshTerm":"Venlafaxine Hydrochloride" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000068760", "InterventionAncestorTerm":"Serotonin and Noradrenaline Reuptake Inhibitors" },{ "InterventionAncestorId":"D000014179", "InterventionAncestorTerm":"Neurotransmitter Uptake Inhibitors" },{ "InterventionAncestorId":"D000049990", "InterventionAncestorTerm":"Membrane Transport Modulators" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000018687", "InterventionAncestorTerm":"Antidepressive Agents, Second-Generation" },{ "InterventionAncestorId":"D000000928", "InterventionAncestorTerm":"Antidepressive Agents" },{ "InterventionAncestorId":"D000011619", "InterventionAncestorTerm":"Psychotropic Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M439", "InterventionBrowseLeafName":"Venlafaxine Hydrochloride", "InterventionBrowseLeafAsFound":"Venlafaxine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M11158", "InterventionBrowseLeafName":"Norepinephrine", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M14095", "InterventionBrowseLeafName":"Serotonin", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M305", "InterventionBrowseLeafName":"Serotonin and Noradrenaline Reuptake Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2828", "InterventionBrowseLeafName":"Antidepressive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M13057", "InterventionBrowseLeafName":"Psychotropic Drugs", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"PsychDr", "InterventionBrowseBranchName":"Psychotropic Drugs" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"VaCoAg", "InterventionBrowseBranchName":"Vasoconstrictor 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" } ] } } } } } }