{
  "FullStudy":{
    "Rank":218076,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513044",
          "OrgStudyIdInfo":{
            "OrgStudyId":"08-VIN-182"
          },
          "Organization":{
            "OrgFullName":"Dr. Reddy's Laboratories Limited",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting 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 Fasting Conditions."
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2009"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2009",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 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":"Yes"
        },
        "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 fasting 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 Fasting conditions. 72 healthy male adults were enrolled. A washout period of 7 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":"68",
            "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, 0.083, 0.167, 0.25, 0.333, 0.41, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 post dose"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects aged between 18 and 50 years (including both).\nSubjects' weight within the normal range according to normal values for the Body\nMass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight.\nSubjects with clinically acceptable normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range.\nSubjects having clinically acceptable 12-lead electrocardiogram (ECG).\nSubjects having clinically acceptable chest X-Ray (PIA view).\nSubjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).\nSubjects having negative alcohol breath test.\nSubjects willing to adhere to the protocol requirements and to provide written informed consent.\n\nExclusion Criteria:\n\nThe subjects were excluded from the study, if they meet any of the following criteria:\n\nHypersensitivity to Mycophenolate Mofetil or related drugs.\nHistory or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.\nHistory or presence of significant alcoholism or drug abuse in the past one year.\nHistory or presence of significant smoking (more than 10 cigarettes day or consumption of tobacco products).\nHistory or presence of asthma, urticaria or other significant allergic reactions.\nHistory or presence of significant gastric and/or duodenal ulceration.\nHistory or presence of glaucoma, prostatic hypertrophy or obstruction of the bladder neck, cardio-spasm and myasthenia gravis.\nHistory or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.\nHistory or presence of cancer.\nDifficulty with donating blood.\nDifficulty in swallowing solids like tablets or capsules.\nUse of any prescribed medication or OTC medicinal products during the last two week prior to initiation of study.\nMajor illness during 3 months before screening.\nParticipation in a drug research study within past 3 months.\nDonation of blood in the past 3 months before screening.\nPositive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.\nHistory or presence of significant easy bruising or bleeding.\nHistory or presence of significant recent trauma.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"50 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jinesh Shah, MD",
                "OverallOfficialAffiliation":"veeda clinical research Pvt. Ltd",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"veeda clinical research Pvt. Ltd",
                "LocationCity":"Ahmedabad",
                "LocationState":"Gujarat",
                "LocationZip":"3 80 015",
                "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"
              }
            ]
          }
        }
      }
    }
  }
}