{
  "FullStudy":{
    "Rank":218003,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514019",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2012_Acebutolol"
          },
          "Organization":{
            "OrgFullName":"Seoul National University Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"An Open-label, Single-dose, Two-treatment, Randomized, Cross-over Study to Investigate the Effects of the SLCO2B1 c.1457C>T Polymorphism and Apple Juice on the Pharmacokinetics and Pharmacodynamics of Acebutolol in Healthy Korean and Japanese Volunteers",
          "OfficialTitle":"An Open-label, Single-dose, Two-treatment, Randomized, Cross-over Study to Investigate the Effects of the SLCO2B1 c.1457C>T Polymorphism and Apple Juice on the Pharmacokinetics and Pharmacodynamics of Acebutolol in Healthy Korean and Japanese Volunteers"
        },
        "StatusModule":{
          "StatusVerifiedDate":"June 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"June 19, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"June 20, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"In-Jin Jang, MD, PhD",
            "ResponsiblePartyInvestigatorTitle":"Professor of Clinical Pharmacology and Therapeutics",
            "ResponsiblePartyInvestigatorAffiliation":"Seoul National University Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"In-Jin Jang, MD, PhD",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Oita University",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Seoul National University Hospital",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Kyushu University",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the SLCO2B1 c.1457C>T polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "SLCO2B1 genotype",
              "effect of apple juice"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"16",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Acebutolol",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Acebutolol 200 mg capsule (Acetanol®)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Acebutolol"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Acebutolol",
                "InterventionDescription":"Acebutolol",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Acebutolol"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Acebutolol 200 mg capsule (Acetanol®)"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Placebo",
                "InterventionDescription":"Placebo capsule(Capsules filled up with lactose)",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Placebo capsule(Capsules filled up with lactose)"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"AUC of acebutolol according to the SLCO2B1 genotypes",
                "PrimaryOutcomeDescription":"The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear/log trapezoidal method will be summarized by treatment and genotype group using descriptive statistics.",
                "PrimaryOutcomeTimeFrame":"0-24 hr after drug administration"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Blood pressure of the subjects who administered acebutolol according to the SLCO2B1 genotypes",
                "SecondaryOutcomeDescription":"Blood pressure (systolic, diastolic) measurement will be presented as descriptive statistics for the difference from baseline where appropriate.",
                "SecondaryOutcomeTimeFrame":"0-24 hr after drug admnistration"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nSubject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures\n\nExclusion Criteria:\n\nA subject with history of allergies including study drug (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"20 Years",
          "MaximumAge":"50 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Kyoichi Ohashi, MD, PhD",
                "OverallOfficialAffiliation":"Department of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine, Oita, Japan",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"General Clinical Research Center, Oita University Hospital",
                "LocationCity":"Oita",
                "LocationCountry":"Japan"
              },{
                "LocationFacility":"Seoul National University Hospital",
                "LocationCity":"Seoul",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000000070",
                "InterventionMeshTerm":"Acebutolol"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000889",
                "InterventionAncestorTerm":"Anti-Arrhythmia Agents"
              },{
                "InterventionAncestorId":"D000000959",
                "InterventionAncestorTerm":"Antihypertensive Agents"
              },{
                "InterventionAncestorId":"D000013566",
                "InterventionAncestorTerm":"Sympathomimetics"
              },{
                "InterventionAncestorId":"D000001337",
                "InterventionAncestorTerm":"Autonomic Agents"
              },{
                "InterventionAncestorId":"D000018373",
                "InterventionAncestorTerm":"Peripheral Nervous System Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000058671",
                "InterventionAncestorTerm":"Adrenergic beta-1 Receptor Antagonists"
              },{
                "InterventionAncestorId":"D000000319",
                "InterventionAncestorTerm":"Adrenergic beta-Antagonists"
              },{
                "InterventionAncestorId":"D000018674",
                "InterventionAncestorTerm":"Adrenergic Antagonists"
              },{
                "InterventionAncestorId":"D000018663",
                "InterventionAncestorTerm":"Adrenergic Agents"
              },{
                "InterventionAncestorId":"D000018377",
                "InterventionAncestorTerm":"Neurotransmitter Agents"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M518",
                "InterventionBrowseLeafName":"Acebutolol",
                "InterventionBrowseLeafAsFound":"Acebutolol",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2794",
                "InterventionBrowseLeafName":"Anti-Arrhythmia Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2858",
                "InterventionBrowseLeafName":"Antihypertensive Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M14928",
                "InterventionBrowseLeafName":"Sympathomimetics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19330",
                "InterventionBrowseLeafName":"Adrenergic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M27784",
                "InterventionBrowseLeafName":"Adrenergic beta-1 Receptor Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2252",
                "InterventionBrowseLeafName":"Adrenergic beta-Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19339",
                "InterventionBrowseLeafName":"Adrenergic Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19088",
                "InterventionBrowseLeafName":"Neurotransmitter Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"AnArAg",
                "InterventionBrowseBranchName":"Anti-Arrhythmia Agents"
              },{
                "InterventionBrowseBranchAbbrev":"AnAg",
                "InterventionBrowseBranchName":"Antihypertensive Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        }
      }
    }
  }
}