{
  "FullStudy":{
    "Rank":218149,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512095",
          "OrgStudyIdInfo":{
            "OrgStudyId":"GH-3958"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2012-003381-40",
                "SecondaryIdType":"EudraCT Number"
              },{
                "SecondaryId":"U1111-1122-9661",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"WHO"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Novo Nordisk A/S",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers",
          "OfficialTitle":"A Trial to Examine the Bioequivalence of Norditropin® Versus Nutropin AQ® in Healthy Adult Volunteers"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2013",
          "OverallStatus":"Withdrawn",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2013"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2013",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2013",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 9, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 13, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 16, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Novo Nordisk A/S",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This trial is conducted in Europe and United States of America (USA). The aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® versus Nutropin AQ® in healthy adult volunteers."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Growth Disorder",
              "Healthy"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"0",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Norditropin®",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: somatropin"
                  ]
                }
              },{
                "ArmGroupLabel":"Nutropin AQ®",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: somatropin"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"somatropin",
                "InterventionDescription":"A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Norditropin®"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"somatropin",
                "InterventionDescription":"A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Nutropin AQ®"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Area under the serum hGH (human growth hormone) concentration-time curve (AUC0-t)",
                "PrimaryOutcomeTimeFrame":"From 0 to the time of the last quantifiable concentration over a 24-hour sampling period"
              },{
                "PrimaryOutcomeMeasure":"Maximum observed serum hGH concentration",
                "PrimaryOutcomeTimeFrame":"Over a 24-hour sampling period"
              },{
                "PrimaryOutcomeMeasure":"Area under the effect (IGF-I) curve from time 0 to the time of the last concentration (AUEC0-t)",
                "PrimaryOutcomeTimeFrame":"Over a 96-hour sampling period"
              },{
                "PrimaryOutcomeMeasure":"Maximum IGF-I (insulin-like growth factor-I) effect (Emax)",
                "PrimaryOutcomeTimeFrame":"Over a 96-hour sampling period"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"The frequency of adverse events (AE) and vital signs",
                "SecondaryOutcomeTimeFrame":"From screening (14 days before randomisation) to follow-up period (3-21 days after randomisation)"
              },{
                "SecondaryOutcomeMeasure":"The frequency of abnormal hematology",
                "SecondaryOutcomeTimeFrame":"From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)"
              },{
                "SecondaryOutcomeMeasure":"The frequency of abnormal findings in physical examinations",
                "SecondaryOutcomeTimeFrame":"From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)"
              },{
                "SecondaryOutcomeMeasure":"Biochemistry laboratory parameters",
                "SecondaryOutcomeTimeFrame":"From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)"
              },{
                "SecondaryOutcomeMeasure":"The frequency of injection site reaction",
                "SecondaryOutcomeTimeFrame":"From the time of injection of the trial product (day 1 and day 13) to follow-up during the two dosing periods (day 5 and day 17)"
              },{
                "SecondaryOutcomeMeasure":"Area under the effect (IGFBP-3) curve",
                "SecondaryOutcomeTimeFrame":"From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period"
              },{
                "SecondaryOutcomeMeasure":"Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax)",
                "SecondaryOutcomeTimeFrame":"Over a 96-hour sampling period"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nNo previous exposure to recombinant human GH (growth hormone)or IGF-I (insulin-like growth factor-I)\nBody mass index (BMI) 18.0-27.0 kg/m^2 (both inclusive)\nConsidered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results, and electrocardiogram (ECG), as judged by the Investigator\n\nExclusion Criteria:\n\nThe receipt of any investigational medicinal product within 1 month prior to this trial\nCurrent or previous treatment with recombinant human growth hormone or IGF-I\nFemale of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures as required by local law) for the duration of the trial\nKnown presence or history of malignancy\nDiabetes mellitus\nUse of pharmacologic doses of glucocorticoids\nUse of anabolic steroids\nHistory of drug or alcohol abuse",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"40 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"John Germak",
                "OverallOfficialAffiliation":"Novo Nordisk A/S",
                "OverallOfficialRole":"Study Director"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Clinical Trials at Novo Nordisk",
                "SeeAlsoLinkURL":"http://novonordisk-trials.com"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020",
          "RemovedCountryList":{
            "RemovedCountry":[
              "United Kingdom",
              "United States"
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006130",
                "ConditionMeshTerm":"Growth Disorders"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M7813",
                "ConditionBrowseLeafName":"Growth Disorders",
                "ConditionBrowseLeafAsFound":"Growth Disorders",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}