{ "FullStudy":{ "Rank":218178, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511718", "OrgStudyIdInfo":{ "OrgStudyId":"3874/06-07" }, "Organization":{ "OrgFullName":"Dr. Reddy's Laboratories Limited", "OrgClass":"INDUSTRY" }, "BriefTitle":"Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fed Condition", "OfficialTitle":"Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Ondansetron Hydrochloride Tablets 8 mg With Zofran® (Containing Ondansetron Hydrochloride Dihydrate) Tablets 8 mg in Healthy, Adult, Human Subjects Under Fed Condition." }, "StatusModule":{ "StatusVerifiedDate":"October 2006", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"October 2006" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2006", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2006", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 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":"No" }, "DescriptionModule":{ "BriefSummary":"This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study.", "DetailedDescription":"The study was an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study of Ondansetron Hydrochloride tablets 8 mg of Dr. Reddy's Laboratories Limited, India comparing with that of Zofran® (containing Ondansetron Hydrochloride Dihydrate) tablets 8 mg of GlaxoSmithKline, USA in healthy, adult, human subjects under fed condition. 26 subjects are enrolled in the study, and 23 subjects are completed the study." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Healthy" ] }, "KeywordList":{ "Keyword":[ "Bioequivalence", "Ondansetron", "crossover" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"26", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Ondansetron Hydrochloride Tablets 8 mg", "ArmGroupType":"Experimental", "ArmGroupDescription":"Ondansetron Hydrochloride Tablets 8 mg of Dr. Reddy's Laboratories Limited", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Ondansetron Hydrochloride" ] } },{ "ArmGroupLabel":"Zofran Tablets 8 mg", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Zofran Tablets 8 mg of GlaxoSmithKline", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Ondansetron Hydrochloride" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Ondansetron Hydrochloride", "InterventionDescription":"Ondansetron Hydrochloride Tablets 8 mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Ondansetron Hydrochloride Tablets 8 mg" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Ondansetron Hydrochloride 8 mg (Dr. Reddy's Laboratories Limited)" ] } },{ "InterventionType":"Drug", "InterventionName":"Ondansetron Hydrochloride", "InterventionDescription":"Zofran Tablets 8 mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Zofran Tablets 8 mg" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Area unde curve (AUC)", "PrimaryOutcomeTimeFrame":"First one was within 1 hour prior to drug administration (0.0) and others at 0.33,0.67,1,1.33, 1.67, 2, 2.5, 3, 3.5,4,6,9,12,15,18 and 24 hours" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects who provide written informed consent.\nSubjects who were healthy adults within 18 and 45 years of age (both inclusive).\nBody mass index of ≥ 18 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.\nSubjects who had normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period I.\nHad normal ECG, Chest X-ray and vital signs\nAvailability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.\nIf subject is a female volunteer and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s),such as condoms, foams, jellies, diaphragm, intrauterine device(IUD), or abstinence.\n\nor\n\nis postmenopausal for at least 1 year or\nis surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)\nEach female subject were supposed to undergo a urine pregnancy test to check-in for period-I, period-II and post study.\n\nExclusion Criteria:\n\nSubjects incapable of understanding the informed consent.\nSubjects BP ≤ 9060 mm/Hg or BP ≥ 140/90 mm/Hg.\nHistory of hypersensitivity or idiosyncratic reaction to ondansetron or any other related drugs.\nAny evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function. Subjects with a history of tuberculosis, epilepsy, asthma(during past 5 years), diabetes, psychosis or glaucoma were not eligible for the study.\nRegular smoker who smokes more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.\nSubjects who has taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication with the past 30 days prior to dosing in Period-I.\nHistory of any psychiatric illness, which may impair the ability to provide written informed consent.\nSubjects who have a history of alcohol or substance abuse within the last 5 years.\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 350 mL in the past 3 months.\nSubjects who are unable to or likely to be non-complaint with protocol requirements or restrictions.\nAny subject in whom ondansetron is contraindicated for medical reasons.\nSubjects who are intolerant to venipuncture.\nSubjects with positive urine screen for drugs of abuse. All subjects urine samples assayed for the presence of drugs of abuse at each study period check-in. Subjects who found to have urine concentrations of any of the tested drugs were not allowed to participate.\nFemale volunteers who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives with 14 days before dosing.\nFemale volunteers who are not negative in pregnancy test\nAll female subjects were to be screened for pregnancy at check in of each study period. Subjects with positive or inconclusive results were to be withdrawn from the study.\nFemale volunteers who are currently breast feeding.\nFemale subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study were not to be allowed to participate. Female subjects of child bearing potential must either abstain form sexual intercourse or use a reliable barrier method (e.g condom, IUD) or contraception during the course of the study (first dosing until last blood collection) or they were not to be allowed to participate.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"45 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Dr. I.S Gandhi", "OverallOfficialAffiliation":"Vimta Labs Limited", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Vimta Labs Limited", "LocationCity":"Hyderabad", "LocationState":"Andhra Pradesh", "LocationZip":"500 051", "LocationCountry":"India" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000017294", "InterventionMeshTerm":"Ondansetron" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000932", "InterventionAncestorTerm":"Antiemetics" },{ "InterventionAncestorId":"D000001337", "InterventionAncestorTerm":"Autonomic Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000005765", "InterventionAncestorTerm":"Gastrointestinal Agents" },{ "InterventionAncestorId":"D000000982", "InterventionAncestorTerm":"Antipruritics" },{ "InterventionAncestorId":"D000003879", "InterventionAncestorTerm":"Dermatologic Agents" },{ "InterventionAncestorId":"D000012702", "InterventionAncestorTerm":"Serotonin Antagonists" },{ "InterventionAncestorId":"D000018490", "InterventionAncestorTerm":"Serotonin Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000014150", "InterventionAncestorTerm":"Antipsychotic Agents" },{ "InterventionAncestorId":"D000014149", "InterventionAncestorTerm":"Tranquilizing Agents" },{ "InterventionAncestorId":"D000002492", "InterventionAncestorTerm":"Central Nervous System Depressants" },{ "InterventionAncestorId":"D000011619", "InterventionAncestorTerm":"Psychotropic Drugs" },{ "InterventionAncestorId":"D000014151", "InterventionAncestorTerm":"Anti-Anxiety Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M18171", "InterventionBrowseLeafName":"Ondansetron", "InterventionBrowseLeafAsFound":"Ondansetron", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2832", "InterventionBrowseLeafName":"Antiemetics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7464", "InterventionBrowseLeafName":"Gastrointestinal Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M5657", "InterventionBrowseLeafName":"Dermatologic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M14095", "InterventionBrowseLeafName":"Serotonin", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15487", "InterventionBrowseLeafName":"Antipsychotic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M13057", "InterventionBrowseLeafName":"Psychotropic Drugs", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15488", "InterventionBrowseLeafName":"Anti-Anxiety Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"AnEm", "InterventionBrowseBranchName":"Antiemetics" },{ "InterventionBrowseBranchAbbrev":"CNSDep", "InterventionBrowseBranchName":"Central Nervous System Depressants" },{ "InterventionBrowseBranchAbbrev":"PsychDr", "InterventionBrowseBranchName":"Psychotropic Drugs" },{ "InterventionBrowseBranchAbbrev":"Derm", "InterventionBrowseBranchName":"Dermatologic Agents" },{ "InterventionBrowseBranchAbbrev":"Gast", "InterventionBrowseBranchName":"Gastrointestinal Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "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" } ] } } } } } }