{
  "FullStudy":{
    "Rank":217936,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514903",
          "OrgStudyIdInfo":{
            "OrgStudyId":"HM-SIL-102"
          },
          "Organization":{
            "OrgFullName":"Hanmi Pharmaceutical Company Limited",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 11, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 12, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Hanmi Pharmaceutical Company Limited",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra (tablet) in healthy male subjects."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Erectile Dysfunction"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "anti erectile dysfunction agent"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"54",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"viagra,anti-erectile dysfunction agent",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: viagra"
                  ]
                }
              },{
                "ArmGroupLabel":"HIP0908",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: HIP0908"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"HIP0908",
                "InterventionDescription":"SINGLE DOSE , CROSS OVER",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "HIP0908"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"viagra",
                "InterventionDescription":"single dose, cross over",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "viagra,anti-erectile dysfunction agent"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"AUC and Cmax of sildenafil",
                "PrimaryOutcomeTimeFrame":"Pre-dose (0h), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hr post-dose"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nage between 20 and 45\nweight : over 55kg and 18.5 < BMI, 25.0\nhave to give their consent to participating clinical trial by oneself\n\nExclusion Criteria:\n\nhas a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc > 430ms or uncontrolled arrhythmia",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Male",
          "MinimumAge":"20 Years",
          "MaximumAge":"45 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Sinchon Severance Hospital",
                "LocationCity":"Seoul",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000068677",
                "InterventionMeshTerm":"Sildenafil Citrate"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000014665",
                "InterventionAncestorTerm":"Vasodilator Agents"
              },{
                "InterventionAncestorId":"D000058986",
                "InterventionAncestorTerm":"Phosphodiesterase 5 Inhibitors"
              },{
                "InterventionAncestorId":"D000010726",
                "InterventionAncestorTerm":"Phosphodiesterase Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000064804",
                "InterventionAncestorTerm":"Urological Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M292",
                "InterventionBrowseLeafName":"Sildenafil Citrate",
                "InterventionBrowseLeafAsFound":"Viagra",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M19904",
                "InterventionBrowseLeafName":"Citric Acid",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M1837",
                "InterventionBrowseLeafName":"Sodium Citrate",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M15995",
                "InterventionBrowseLeafName":"Vasodilator Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M27919",
                "InterventionBrowseLeafName":"Phosphodiesterase 5 Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M12212",
                "InterventionBrowseLeafName":"Phosphodiesterase Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"T382",
                "InterventionBrowseLeafName":"Citrate",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"VaDiAg",
                "InterventionBrowseBranchName":"Vasodilator Agents"
              },{
                "InterventionBrowseBranchAbbrev":"Urol",
                "InterventionBrowseBranchName":"Urological Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"AnCoag",
                "InterventionBrowseBranchName":"Anticoagulants"
              },{
                "InterventionBrowseBranchAbbrev":"Ot",
                "InterventionBrowseBranchName":"Other Dietary Supplements"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000007172",
                "ConditionMeshTerm":"Erectile Dysfunction"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012735",
                "ConditionAncestorTerm":"Sexual Dysfunction, Physiological"
              },{
                "ConditionAncestorId":"D000005832",
                "ConditionAncestorTerm":"Genital Diseases, Male"
              },{
                "ConditionAncestorId":"D000020018",
                "ConditionAncestorTerm":"Sexual Dysfunctions, Psychological"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8800",
                "ConditionBrowseLeafName":"Erectile Dysfunction",
                "ConditionBrowseLeafAsFound":"Erectile Dysfunction",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14129",
                "ConditionBrowseLeafName":"Sexual Dysfunction, Physiological",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7527",
                "ConditionBrowseLeafName":"Genital Diseases, Male",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20457",
                "ConditionBrowseLeafName":"Sexual Dysfunctions, Psychological",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}