{
  "FullStudy":{
    "Rank":218075,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513057",
          "OrgStudyIdInfo":{
            "OrgStudyId":"466-08"
          },
          "Organization":{
            "OrgFullName":"Dr. Reddy's Laboratories Limited",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fed Conditions",
          "OfficialTitle":"An Open-label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Bioequivalence Study in Healthy, Adult,Human, Male Subjects Under Fed Conditions."
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2009"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2009",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2009",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 19, 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":"An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr. Reddy's Laboratories limited, comparing with that of Cellcept 250 mg Capsule of Roche Laboratories in healthy, adult, human, male subjects under fed conditions.",
          "DetailedDescription":"This was an open-label, balanced, randomized, two-treatment, two-sequence, two-period, single dose, crossover bioequivalence study in healthy, adult, human, male subjects under fed conditions.64 healthy male adults were enrolled.A washout period of 07 days was maintained between the successive dosing days.One capsule containing mycophenolate mofetil 250 mg was administered orally with 240 mL water in sitting posture, after an overnight fast of at least 10 hours in each period. This activity was followed by a mouth check to assess compliance to dosing. The subjects were not allowed to lie down for the first two hours after dosing."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "bioequivalence",
              "Mycophenolate Mofetil",
              "crossover"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"61",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Mycophenolate Mofetil",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Mycophenolate Mofetil"
                  ]
                }
              },{
                "ArmGroupLabel":"Cellcept",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Cellcept 250 mg capsules of Roche Laboratories Inc.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Mycophenolate Mofetil"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Mycophenolate Mofetil",
                "InterventionDescription":"Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Mycophenolate Mofetil"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Mycophenolate Mofetil",
                "InterventionDescription":"250 mg capsules of Roche Laboratories Inc.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Cellcept"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Cellcept"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Area Under Curve (AUC)",
                "PrimaryOutcomeTimeFrame":"pre-dose, 0.167, 0.333,. 0.500, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 hours post dose"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy, adult, human male volunteers between 18 - 55 years of age (both inclusive) living in and around Ahmedabad city of western part of India.\nHaving a Body Mass Index (BMI) between 18.5 - 24.9 (both inclusive), calculated as weight in kg/height in meter2.\nHave no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest recordings.\nAble to comply with the study procedures, in the opinion of the Principal investigator.\nAble to give voluntary written informed consent for participation in the study.\n\nExclusion Criteria:\n\nKnown hypersensitivity or idiosyncratic reaction to Mycophenolate mofetil or any related drug.\nAny disease or condition that compromised the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.\nIngestion of a medicine at any time with in 14 days before dosing in Period-I. In any such case subject selection was at the discretion of the Principal Investigator.\nAny history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.\nA recent history of alcoholism (< 2 years) or of moderate (180 mL/day) alcohol use, or consumption of alcohol within 48 hours prior to receiving study medicine.\nSmokers, who smoked 10 or more than 10 cigarettes/day or inability to abstain from smoking during the study.\nConsumption of Grapefruits or its products within a period of 48 hours prior to dosing.\nThe presence of clinically significant abnormal laboratory values during screening.\nUse of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.\nHistory of psychiatric disorders.\nA history of difficulty with donating blood.\nDonation of blood (1 unit or 350 mL) or receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study medicine. Elimination half-life of the study drug was taken into consideration for inclusion of the subject in the study.\n\nNote: If subject had participated in a study in which blood loss was ≤ 200 mL, subject could be enrolled 60 days after the last sample of previous study.\n\nA positive hepatitis screen including hepatitis B surface antigen and HCV antibodies.\nA positive test result for HIV antibody and/or syphilis.\nAn unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to receiving the study medicine and throughout the subjects' participation in the study. In any such case subject selection was at the discretion of the Principal Investigator.\n\nAll the enrolled subjects satisfied all the above inclusion and exclusion criteria.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Pankaj Kumar Jha, MD",
                "OverallOfficialAffiliation":"Lambda Therapeutic Research Ltd.",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Lambda Therapeutic Research Ltd",
                "LocationCity":"Ahmedabad",
                "LocationState":"Gujarat",
                "LocationZip":"3 80 061",
                "LocationCountry":"India"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000009173",
                "InterventionMeshTerm":"Mycophenolic Acid"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000903",
                "InterventionAncestorTerm":"Antibiotics, Antineoplastic"
              },{
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              },{
                "InterventionAncestorId":"D000000904",
                "InterventionAncestorTerm":"Antibiotics, Antitubercular"
              },{
                "InterventionAncestorId":"D000000995",
                "InterventionAncestorTerm":"Antitubercular Agents"
              },{
                "InterventionAncestorId":"D000000900",
                "InterventionAncestorTerm":"Anti-Bacterial Agents"
              },{
                "InterventionAncestorId":"D000000890",
                "InterventionAncestorTerm":"Anti-Infective Agents"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M10711",
                "InterventionBrowseLeafName":"Mycophenolic Acid",
                "InterventionBrowseLeafAsFound":"Mycophenolate mofetil",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2803",
                "InterventionBrowseLeafName":"Anti-Bacterial Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2805",
                "InterventionBrowseLeafName":"Antibiotics, Antitubercular",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2892",
                "InterventionBrowseLeafName":"Antitubercular Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2795",
                "InterventionBrowseLeafName":"Anti-Infective Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic 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"
              }
            ]
          }
        }
      }
    }
  }
}