{
  "FullStudy":{
    "Rank":218119,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512485",
          "OrgStudyIdInfo":{
            "OrgStudyId":"60281"
          },
          "Organization":{
            "OrgFullName":"Dr. Reddy's Laboratories Limited",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Bioequivalence Study of Clopidogrel Tablets 75 mg Under Fed Conditions",
          "OfficialTitle":"Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopidogrel 75 mg Tablet With Plavix® 75 mg In Healthy Subjects Under Fed Conditions"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2006"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"October 2006",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 2006",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 10, 2012",
          "StudyFirstSubmitQCDate":"January 13, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 13, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 19, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Dr. Reddy's Laboratories Limited",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75 mg tablet under fed condition.",
          "DetailedDescription":"Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopidogrel 75 mg Tablet (Dr. Reddy's Laboratories Ltd., India) and Plavix® (Bristol-Myers Squibb Company, USA) Following a 75 mg Dose In Healthy Subjects Under Fed Conditions."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Healthy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Bioequivalence",
              "Clopidogrel",
              "crossover"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"51",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Clopidogrel",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Clopidogrel tablets 75 mg of Dr. Reddy's Laboratories Limited",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Clopidogrel"
                  ]
                }
              },{
                "ArmGroupLabel":"Plavix",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Clopidogrel Tablet 75 mg",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Clopidogrel"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Clopidogrel",
                "InterventionDescription":"Clopidogrel Tablets 75 mg",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Clopidogrel",
                    "Plavix"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Plavix"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Area Under Curve (AUC)",
                "PrimaryOutcomeTimeFrame":"predose, 0.250, 0.500, 0.750, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 12.0, 16.0, and 24.0 hours post-dose"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e.g. radio, newspaper, Anapharm Web site, Anapharm volunteers' database). Subjects must meet all of the following criteria to be included in the study:\n\nMale or female, non-smoker, ≥18 and ≤55 years of age.\nMedically healthy with clinically normal laboratory profile, vital signs and ECG.\nCapable of consent.\nBMI ≥19.0 and <30.0\n\nExclusion Criteria:\n\nSubjects to whom any of the following applies will be excluded from the study:\n\nClinically significant illness or surgery within 4 weeks prior to dosing.\nAny clinically significant abnormality or abnormal laboratory test results found during medical screening.\nAny reason which, in the opinion of the Clinical Sub-.investigator, would prevent the subject from participating in the study.\nPositive test for hepatitis B, hepatitis C, or HIV at screening.\nECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or• heart rate less than 50 or over J00 bpm) at screening.\nHistory of significant alcohol abuse or drug abuse within one year prior to the screening visit.\nRegular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [J Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]), or positive alcohol breath test at screening.\nUse of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine (PCP] and -crack) within 1 year prior to the screening visit or positive urine drug screen at screening.\nHistory of allergic reactions to clopidogrel or other related drugs.\nUse of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fIuoroquinolones, antihistamines) within 30 days prior to administration of the study medication.\nUse of an investigational drug or participation in an investigational study within 30 days prior to dosing.\nClinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.\nAny clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, or metabolic disease.\nUse of prescription medication within 14 days prior to administration of study medication or over-the counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption and hormonal contraceptives.\nDifficulty to swallow study medication.\nUse of any tobacco products in the 3 months preceding drug administration.\nAny food allergy, intolerance, restriction or special diet that, in the opinion of the Clinical Sub-Investigator, could contraindicate the subject's participation in this study.\nA depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to administration of study medication.\nDonation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:\n50 mL to 499 mL of whole blood within 30 days,\nmore than 499 mL of whole blood within 56 days prior to drug administration.\nPositive urine pregnancy test at screening.\nBreast-feeding subject.\nFemale subjects of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration. Acceptable methods of contraception are:\nintra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration;\ncondom or diaphragm + spermicide;\nhormonal contraceptives (starting at least 4 weeks prior to study drug administration).\nHistory or known active pathological bleeding (e.g. peptic ulcer, intracranial hemorrhage).\nIncreased risks of bleeding (e.g. frequent nose bleeding, recent trauma, surgery or other pathological condition).",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Denis Audet, MD",
                "OverallOfficialAffiliation":"Anapharm",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Anapharm",
                "LocationCity":"Sainte-Foy (Quebec)",
                "LocationCountry":"Canada"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000077144",
                "InterventionMeshTerm":"Clopidogrel"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000010975",
                "InterventionAncestorTerm":"Platelet Aggregation Inhibitors"
              },{
                "InterventionAncestorId":"D000058921",
                "InterventionAncestorTerm":"Purinergic P2Y Receptor Antagonists"
              },{
                "InterventionAncestorId":"D000058919",
                "InterventionAncestorTerm":"Purinergic P2 Receptor Antagonists"
              },{
                "InterventionAncestorId":"D000058914",
                "InterventionAncestorTerm":"Purinergic Antagonists"
              },{
                "InterventionAncestorId":"D000058905",
                "InterventionAncestorTerm":"Purinergic Agents"
              },{
                "InterventionAncestorId":"D000018377",
                "InterventionAncestorTerm":"Neurotransmitter Agents"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M1669",
                "InterventionBrowseLeafName":"Clopidogrel",
                "InterventionBrowseLeafAsFound":"Clopidogrel",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M12448",
                "InterventionBrowseLeafName":"Platelet Aggregation Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M27881",
                "InterventionBrowseLeafName":"Purinergic P2Y Receptor Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19088",
                "InterventionBrowseLeafName":"Neurotransmitter Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"PlAggInh",
                "InterventionBrowseBranchName":"Platelet Aggregation Inhibitors"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000044342",
                "ConditionMeshTerm":"Malnutrition"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000009748",
                "ConditionAncestorTerm":"Nutrition Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M23893",
                "ConditionBrowseLeafName":"Malnutrition",
                "ConditionBrowseLeafAsFound":"Under Fed",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M11267",
                "ConditionBrowseLeafName":"Nutrition Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}