{
  "FullStudy":{
    "Rank":217968,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514487",
          "OrgStudyIdInfo":{
            "OrgStudyId":"NN2211-1636"
          },
          "Organization":{
            "OrgFullName":"Novo Nordisk A/S",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Comparison of Three Liraglutide Formulations in Healthy Volunteers",
          "OfficialTitle":"A Randomised, Double-blind, Single-centre, Three-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Each of the Two New Liraglutide Formulations at pH 7.9 and 8.15 and the Planned Phase 3 Formulation at pH 7.7"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2017",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 13, 2005",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 30, 2005",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 30, 2005",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 28, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 1, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Novo Nordisk A/S",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase 3 formulation at pH 7.7."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Diabetes",
              "Healthy"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"24",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"pH 7.7",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: liraglutide"
                  ]
                }
              },{
                "ArmGroupLabel":"pH 7.9",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: liraglutide"
                  ]
                }
              },{
                "ArmGroupLabel":"pH 8.15",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: liraglutide"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"liraglutide",
                "InterventionDescription":"One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "pH 7.7",
                    "pH 7.9",
                    "pH 8.15"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Area under the Curve (0-t)"
              },{
                "PrimaryOutcomeMeasure":"Cmax, maximum concentration"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Area under the curve (0-infinity)"
              },{
                "SecondaryOutcomeMeasure":"tmax, time to reach Cmax"
              },{
                "SecondaryOutcomeMeasure":"t½, terminal half-life"
              },{
                "SecondaryOutcomeMeasure":"Terminal elimination rate constant"
              },{
                "SecondaryOutcomeMeasure":"Adverse events"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy subjects\nGood general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments.\nBody Mass Index (BMI) of 18-27 kg/m^2, both inclusive\n\nExclusion Criteria:\n\nHistory of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal,\nmetabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders\nthat may interfere with the objectives of the study, as judged by the investigator\nFamily or personal history of Primary hyperparathyroidism or pheochromocytoma or thyroid malignancy or multiple endocrine neoplasia\nImpaired renal function\nUncontrolled treated/untreated hypertension\nAny clinically significant abnormal ECG\nActive hepatitis B and/or active hepatitis C\nPositive HIV (human immunideficiency virus) antibodies\nKnown or suspected allergy to trial product(s) or related products\nPregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures\nPrescription or non-prescription medication, except for paracetamol and vitamins\nHistory of alcoholism or drug abuse during the last 12 months\nSmoking of more than 10 cigarettes per day, or the equivalent for other tobacco products\nHabitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the Investigator",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"50 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Global Clinical Registry (GCR, 1452)",
                "OverallOfficialAffiliation":"Novo Nordisk A/S",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Novo Nordisk Investigational Site",
                "LocationCity":"Adelaide",
                "LocationZip":"5000",
                "LocationCountry":"Australia"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Clinical Trials at Novo Nordisk",
                "SeeAlsoLinkURL":"http://novonordisk-trials.com"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000069450",
                "InterventionMeshTerm":"Liraglutide"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000007004",
                "InterventionAncestorTerm":"Hypoglycemic Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000054795",
                "InterventionAncestorTerm":"Incretins"
              },{
                "InterventionAncestorId":"D000006728",
                "InterventionAncestorTerm":"Hormones"
              },{
                "InterventionAncestorId":"D000006730",
                "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M419",
                "InterventionBrowseLeafName":"Liraglutide",
                "InterventionBrowseLeafAsFound":"Liraglutide",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M8637",
                "InterventionBrowseLeafName":"Hypoglycemic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M26492",
                "InterventionBrowseLeafName":"Incretins",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8372",
                "InterventionBrowseLeafName":"Hormones",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8371",
                "InterventionBrowseLeafName":"Hormone Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Hypo",
                "InterventionBrowseBranchName":"Hypoglycemic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5698",
                "ConditionBrowseLeafName":"Diabetes Mellitus",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}