{
  "FullStudy":{
    "Rank":218177,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511731",
          "OrgStudyIdInfo":{
            "OrgStudyId":"981325"
          },
          "Organization":{
            "OrgFullName":"Dr. Reddy's Laboratories Limited",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions",
          "OfficialTitle":"Open-label, Randomized, 2-way Crossover Study to Compare the Bioavailability of Reddy Cheminor and Merck &Co, Pepcid Famotidine Tablets 40 mg Under Fasting Conditions."
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 1998"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"October 1998",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 1998",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 18, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 19, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Dr. Reddy's Laboratories Limited",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The objective of this study was to compare the single-dose relative bioavailability of Reddy Cheminor and Merck &Co, pepcid 40 mg famotidine tablets under fasting conditions.",
          "DetailedDescription":"Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 30 healthy adult male volunteers. A total of 30 subjects completed the clinical phase of the study. Single oral 40 mg doses were separated by a washout period of 7 days."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Bioequivalence",
              "famotidine",
              "Crossover"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"30",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Famotidine",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Famotidine tablets 40 mg of Dr. Reddy's",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Famotidine"
                  ]
                }
              },{
                "ArmGroupLabel":"Pepcid",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Pepcid 40 mg Tablets of Merck & Co.,",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Pepcid"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Famotidine",
                "InterventionDescription":"Famotidine Tablets 40 mg",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Famotidine"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Reddy Cheminor"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Pepcid",
                "InterventionDescription":"40mg tablets",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Pepcid"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Merck & Co."
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Area Under Curve (AUC)",
                "PrimaryOutcomeTimeFrame":"predose,0. 5, 1, 1. 33, 1. 67, 2, 2. 33, 2.67, 3, 3. 33, 3. 67, 4, 4. 5, 5, 6, 8, 10, 12, 16 and 24 hours post-dose."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nExclusion Criteria:\n\nHistory or presence of significant:\n\n• cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.\n\nIn addition, history or presence of:\n\nalcoholism or drug abuse within the past year;\nhypersensitivity or idiosyncratic reaction to famotidine or any other histamine H2-receptor antagonist; Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.\n\nSubjects who, through completion of the study, would have donated in excess of:\n\n500 mL of blood in 14 days, or\n500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),\n1000 mL of blood in 90 days,\n1250 mL of blood in 120 days,\n1500 mL of blood in 180 days,\n2000 mL of blood in 270 days,\n2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days of study start.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Male",
          "MinimumAge":"18 Years",
          "MaximumAge":"45 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Samuel Serfaty, MD",
                "OverallOfficialAffiliation":"Phoenix Clinical Research Center",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Phoenix Clinical Research Center",
                "LocationCity":"Montreal",
                "LocationCountry":"Canada"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000015738",
                "InterventionMeshTerm":"Famotidine"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000897",
                "InterventionAncestorTerm":"Anti-Ulcer Agents"
              },{
                "InterventionAncestorId":"D000005765",
                "InterventionAncestorTerm":"Gastrointestinal Agents"
              },{
                "InterventionAncestorId":"D000006635",
                "InterventionAncestorTerm":"Histamine H2 Antagonists"
              },{
                "InterventionAncestorId":"D000006633",
                "InterventionAncestorTerm":"Histamine Antagonists"
              },{
                "InterventionAncestorId":"D000018494",
                "InterventionAncestorTerm":"Histamine Agents"
              },{
                "InterventionAncestorId":"D000018377",
                "InterventionAncestorTerm":"Neurotransmitter Agents"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M16886",
                "InterventionBrowseLeafName":"Famotidine",
                "InterventionBrowseLeafAsFound":"Famotidine",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2769",
                "InterventionBrowseLeafName":"Antacids",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2800",
                "InterventionBrowseLeafName":"Anti-Ulcer Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M7464",
                "InterventionBrowseLeafName":"Gastrointestinal Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8291",
                "InterventionBrowseLeafName":"Histamine",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M219111",
                "InterventionBrowseLeafName":"Histamine phosphate",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8294",
                "InterventionBrowseLeafName":"Histamine H2 Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8292",
                "InterventionBrowseLeafName":"Histamine Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19088",
                "InterventionBrowseLeafName":"Neurotransmitter Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Gast",
                "InterventionBrowseBranchName":"Gastrointestinal Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        }
      }
    }
  }
}