Bioequivalence Study Between YHP2305 and YHR2404 in Healthy Volunteers

Launched by YUHAN CORPORATION · Sep 24, 2024

Nctid: NCT06613139

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"CROSSOVER", "interventionModelDescription"=>"Crossover Assignment two-way crossover"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>34}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-10-06", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-11", "completionDateStruct"=>{"date"=>"2024-10-24", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-11-14", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-11-15", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-10-15", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Area under the plasma drug concentration-time curve [AUCt]", "timeFrame"=>"0-36 hours"}, {"measure"=>"Maximum plasma concentration [Cmax]", "timeFrame"=>"0-36 hours"}], "secondaryOutcomes"=>[{"measure"=>"Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]", "timeFrame"=>"0-36 hours"}, {"measure"=>"Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]", "timeFrame"=>"0-36 hours"}, {"measure"=>"Time of peak concentration [Tmax]", "timeFrame"=>"0-36 hours"}, {"measure"=>"Terminal phase of half-life [t1/2]", "timeFrame"=>"0-36 hours"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Pharmacokinetics", "Bioequivalence"], "conditions"=>["Healthy Volunteers"]}, "descriptionModule"=>{"briefSummary"=>"An open-label, randomized, single-dose, oral administration, 2-sequence, 2- period, crossover study to evaluate bioequivalence between YHP2305 and YHR2404 in healthy subjects", "detailedDescription"=>"Subjects in group A will be administered comparator and YHP2305 by crossover design on day 1, 8.\n\nSubjects in group B will be administered YHP2305 and comparator by crossover design on day 1, 8."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"19 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Those who are 19 years old or older at the screening visit\n* Those whose weight is over 50kg(male), over 45kg(female) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2\n* Those who express their voluntary consent to participate in the trial by signing a written consent\n* Those who are judged eligible to participate in the trial by the principal investigator(or delegated investigators) after screening test\n\nExclusion Criteria:\n\n* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.\n* Others who are judged ineligible to participate in the trial by the principal investigator."}, "identificationModule"=>{"nctId"=>"NCT06613139", "briefTitle"=>"Bioequivalence Study Between YHP2305 and YHR2404 in Healthy Volunteers", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Yuhan Corporation"}, "officialTitle"=>"An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2- Period, Crossover Study to Evaluate Bioequivalence Between YHP2305 and YHR2404 in Healthy Subjects", "orgStudyIdInfo"=>{"id"=>"YHP2305-101"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Group A(RT)", "description"=>"17 subjects, Cross-over, Single dose of YHR2404 on day 1, Single dose of YHP2305 on day 8", "interventionNames"=>["Drug: YHP2305", "Drug: YHR2404"]}, {"type"=>"EXPERIMENTAL", "label"=>"Group B(TR)", "description"=>"17 subjects, Cross-over, Single dose of YHP2305 on day 1, Single dose of YHR2404 on day 8", "interventionNames"=>["Drug: YHP2305", "Drug: YHR2404"]}], "interventions"=>[{"name"=>"YHP2305", "type"=>"DRUG", "description"=>"Test drug: YHP2305 Comparator: YHR2404", "armGroupLabels"=>["Group A(RT)", "Group B(TR)"]}, {"name"=>"YHR2404", "type"=>"DRUG", "description"=>"Test drug: YHP2305 comparator: YHR2404", "armGroupLabels"=>["Group A(RT)", "Group B(TR)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"07590", "city"=>"Seoul", "country"=>"Korea, Republic of", "facility"=>"Bumin Hospital", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}], "overallOfficials"=>[{"name"=>"Taegon Hong", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Locations"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Yuhan Corporation", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}