{
  "FullStudy":{
    "Rank":217886,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515553",
          "OrgStudyIdInfo":{
            "OrgStudyId":"NN2211-1692"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2006-004283-31",
                "SecondaryIdType":"EudraCT Number"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Novo Nordisk A/S",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers",
          "OfficialTitle":"A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 3a Formulation of Liraglutide (Formulation 4) and the Planned Phase 3b Formulation (Final Formulation 4)"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2007"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"April 2007",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"April 2007",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 12, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 13, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "LeadSponsor":{
            "LeadSponsorName":"Novo Nordisk A/S",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned for phase 3b trials (final formulation 4)."
        },
        "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":"22",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Formulation 4",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: liraglutide"
                  ]
                }
              },{
                "ArmGroupLabel":"Final formulation 4",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: liraglutide"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"liraglutide",
                "InterventionDescription":"Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Final formulation 4",
                    "Formulation 4"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Area under the curve (0-t)"
              },{
                "PrimaryOutcomeMeasure":"Cmax, maximum concentration"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Area under the curve (0-infinity)"
              },{
                "SecondaryOutcomeMeasure":"Relative bioavailability"
              },{
                "SecondaryOutcomeMeasure":"Time to reach maximum (tmax)"
              },{
                "SecondaryOutcomeMeasure":"Terminal elimination half life (t½)"
              },{
                "SecondaryOutcomeMeasure":"Terminal elimination rate constant"
              },{
                "SecondaryOutcomeMeasure":"Adverse events"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\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\nBMI (Body Mass Index) of 18.0-27.0 kg/m^2, both inclusive\n\nExclusion Criteria:\n\nHistory of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator\nImpaired renal function\nAny clinically significant abnormal ECG, as judged by the Investigator\nActive hepatitis B and/or active hepatitis C\nPositive human immunodeficiency virus (HIV) 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\nHistory of alcoholism or drug abuse, or positive results in alcohol or drug screens\nSmoking of more than 5 cigarettes per day, or the equivalent for other tobacco products\nHabitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator\nExcessive consumption of a diet deviating from a normal diet 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":[
              {
                "LocationCity":"Lund",
                "LocationZip":"221 85",
                "LocationCountry":"Sweden"
              }
            ]
          }
        },
        "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"
              }
            ]
          }
        }
      }
    }
  }
}