[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100312093":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":33,"locations":38,"responsibleParty":50,"collaborators":33,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":33,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":33,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":33,"overallStatus":71,"whyStopped":33,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Otsuka Pharmaceutical Co., Ltd.","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"ASC-01 in period 1, Aripiprazole and sertraline in period 2","EXPERIMENTAL","At Day 1 in Period I, ASC-01 (aripiprazole 3 mg\u002Fsertraline 100 mg combination drug) will be administered after 10 or more hours of fasting.\n\nAt Day 1 in Period II, Aripiprazole 3 mg and sertraline 100 mg will be administered after 10 or more hours of fasting.",[13,14],"Drug: ASC-01","Drug: Aripiprazole and sertraline",{"label":16,"type":10,"description":17,"interventionNames":18},"Aripiprazole and sertraline in period 1, ASC-01 in period 2","At Day 1 in Period I, Aripiprazole 3 mg and sertraline 100 mg will be administered after 10 or more hours of fasting.\n\nAt Day 1 in Period II, ASC-01 (aripiprazole 3 mg\u002Fsertraline 100 mg combination drug) will be administered after 10 or more hours of fasting.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Fasting in period 1, After breakfast in period 2","At Day 1 in Period I, ASC-01 (aripiprazole 3 mg\u002Fsertraline 100 mg combination drug) will be administered after 10 or more hours of fasting.\n\nAt Day 1 in Period II, ASC-01 (aripiprazole 3 mg\u002Fsertraline 100 mg combination drug) will be administered 30 minutes after the start of breakfast.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"After breakfast in period 1, Fasting in period 2","At Day 1 in Period I, ASC-01 (aripiprazole 3 mg\u002Fsertraline 100 mg combination drug) will be administered 30 minutes after the start of breakfast.\n\nAt Day 1 in Period II, ASC-01 (aripiprazole 3 mg\u002Fsertraline 100 mg combination drug) will be administered after 10 or more hours of fasting.",[13,14],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","ASC-01","Aripiprazole 3 mg\u002Fsertraline 100 mg combination drug",[9,24,16,20],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Aripiprazole and sertraline","Aripiprazole 3 mg and sertraline 100 mg",[9,24,16,20],[39],{"facility":40,"status":33,"city":41,"state":33,"zip":33,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":33},"Clinic of Kyusyu Region","Fukuoka","Japan","JP",{"type":45,"coordinates":46},"Point",[47,48],130.41667,33.6,{"lat":48,"lon":47},{"type":51,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100312093","phase-1-bioequivalence-between-single-administration-of-asc-01-aripiprazolesertraline-combination-drug-and-concomitant-single-administration-of-aripiprazole-and-sertraline-and-food-effect-on-pharmacokinetics-of-asc-01-in-healthy-male-adults-100312093",true,"NCT03342963","Bioequivalence Between Single Administration of ASC-01 (Aripiprazole\u002FSertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults","A Single-center, Open-label, Randomized, Two-treatment, Two-period Crossover Trial to Investigate Bioequivalence Between Single Administration of ASC-01 (Aripiprazole\u002FSertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults","Inclusion Criteria:\n\n* Healthy male subject at the age between 20 and 40 at the time of informed consent\n* Subject has a body mass index (BMI = body weight \\[kg\\]\u002Fheight \\[m\\]2) of ≥18.5 and \\\u003C25.0 kg\u002Fm2 at screening\n* Subject is providing consent for participation in this trial in writing prior to the start of the procedures related to this trial, and judged by the investigator or subinvestigator to be capable of observing procedures in this trial.\n\nExclusion Criteria:\n\n* Subject has a clinically significant abnormality in physical findings at screening or in medical history that in the investigator's or subinvestigator's opinion may place the subject at risk or interfere with outcome variables including drug absorption, distribution, metabolism, and excretion.\n* Subject is judged by the investigator or subinvestigator to be inappropriate for participation in this trial.","MALE","20 Years","40 Years",{"count":63,"type":64},74,"ACTUAL","INTERVENTIONAL",[67],"PHASE1","To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet (aripiprazole 3 mg\u002Fsertraline 100 mg combination drug) and concomitant administration of one aripiprazole 3-mg tablet and two sertraline 50-mg tablets (Cohort 1).\n\nTo investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).",[70],"Healthy Male Adults","COMPLETED","2021-04-06",{"date":74,"type":64},"2021-05-03",{"date":76,"type":64},"2017-11-21",{"date":78,"type":64},"2018-01-18",{"name":5,"class":6},1]