Nctid:
NCT06616883
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"T4202", "name"=>"Oculocerebral Syndrome With Hypopigmentation", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Rare Diseases", "abbrev"=>"Rare"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"CROSSOVER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>44}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-11-18", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-11-14", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"AUCt", "timeFrame"=>"pre-dose~72 hours post-dose", "description"=>"area under the curve"}, {"measure"=>"Cmax", "timeFrame"=>"pre-dose~72 hours post-do", "description"=>"maximum plasma concentration"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Healthy"]}, "descriptionModule"=>{"briefSummary"=>"Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"19 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Healthy volunteers\n* BMI between 18 and 30 kg/m2\n* Body weight: Male≥50kg, Female≥45kg\n* Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study\n\nExclusion Criteria:\n\n* Subjects with clinically significant medical history\n* Subjects with history of drug abuse or addicted"}, "identificationModule"=>{"nctId"=>"NCT06616883", "briefTitle"=>"Pharmacokinetics and Safety Profiles After Administration of DA-5221_01 and Co-administration of 5221_01-R1 and DA-5221_01-R2 in Healthy Adult Volunteers", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Dong-A ST Co., Ltd."}, "officialTitle"=>"An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Study to Compare and Evaluate the Safety and Pharmacokinetic Characteristics After Single Administration of DA-5221_01 and Concomitant Administration of DA-5221_01-R1 and DA-5221_01-R2 Under Fasting Conditions in Healthy Adult Volunteers", "orgStudyIdInfo"=>{"id"=>"DA5221_01_BE_I"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Experimental: Sequence A", "interventionNames"=>["Drug: DA-5221_01", "Drug: DA-5221_01-R1 + DA-5221_01-R2"]}, {"type"=>"EXPERIMENTAL", "label"=>"Experimental: Sequence B", "interventionNames"=>["Drug: DA-5221_01", "Drug: DA-5221_01-R1 + DA-5221_01-R2"]}], "interventions"=>[{"name"=>"DA-5221_01", "type"=>"DRUG", "description"=>"single dose administration (DA-5221_01 one tablet once a day)", "armGroupLabels"=>["Experimental: Sequence A", "Experimental: Sequence B"]}, {"name"=>"DA-5221_01-R1 + DA-5221_01-R2", "type"=>"DRUG", "description"=>"single dose administration (DA-5221_01-R1 one tablet once a day + DA-5221_01-R2 one tablet once a day)", "armGroupLabels"=>["Experimental: Sequence A", "Experimental: Sequence B"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"07590", "city"=>"Seoul", "state"=>"South Korea", "country"=>"Korea, Republic of", "contacts"=>[{"name"=>"TaeGon Hong, Ph.D", "role"=>"CONTACT", "email"=>"tghong@bumin.co.kr"}], "facility"=>"Bumin Hospital", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}], "centralContacts"=>[{"name"=>"Sung", "role"=>"CONTACT", "email"=>"jhsung@donga.co.kr", "phone"=>"+82-02-920-8369"}, {"name"=>"Jung", "role"=>"CONTACT", "email"=>"jungjy@donga.co.kr", "phone"=>"+82-02-920-8361"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Dong-A ST Co., Ltd.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
