[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100251880":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":31,"centralContacts":36,"locations":37,"responsibleParty":49,"collaborators":36,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":36,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":36,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":73,"whyStopped":36,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Dong-A ST Co., Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Viread → DA-2802","EXPERIMENTAL","* Viread 300mg(Tenofovir disoproxil fumarate)\n* DA-2802 319mg(Tenofovir disoproxil orotate)",[13,14],"Drug: Viread 300mg","Drug: DA-2802 319mg",{"label":16,"type":10,"description":11,"interventionNames":17},"DA-2802 → Viread",[13,14],[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Viread 300mg","single dose administration after 10hr fasting",[16,9],[25],"Tenofovir disoproxil fumarate",{"type":20,"name":27,"description":22,"armGroupLabels":28,"otherNames":29},"DA-2802 319mg",[16,9],[30],"Tenofovir disoproxil orotate",[32],{"name":33,"affiliation":34,"role":35},"Kyung-sang Yu, Ph.D, M.B.A","Seoul National University Hospital","PRINCIPAL_INVESTIGATOR",null,[38],{"facility":39,"status":36,"city":40,"state":36,"zip":41,"country":42,"countryCode":36,"cosmosGeoPoint":43,"geoPoint":48,"contacts":36},"Clinical Trial Center, Seoul National University Hospital","Seoul","110-744","South Korea",{"type":44,"coordinates":45},"Point",[46,47],126.9784,37.566,{"lat":47,"lon":46},{"type":50,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100251880","phase-1-clinical-trial-to-assess-the-safety-and-pharmacokinetics-of-da-2802-319mg-and-viread-300mg-in-healthy-male-volunteers-100251880",false,"NCT02557594","Clinical Trial to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg in Healthy Male Volunteers","A Randomized, Open-label, Two-way Crossover Study to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg After a Single Oral Dose in Healthy Male Volunteers","Inclusion Criteria:\n\n* Age between 20 to 50, healthy male subjects(at screening)\n* Body weight over 55kg, BMI between 18.0 - 27.0\n* Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.\n\nExclusion Criteria:\n\n* Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, neurology, immunology, pulmonary, endocrine, hematooncology, urinary, skeletomuscular, cardiovascular, mental disorder)\n* Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)\n* Genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance which is contraindication to Viread\n* Volunteer who had hypersensitivity reaction to medicines including Tenofovir, Aspirin, or antibiotics\n* exceed 1.5 times the normal range of AST, ALT at screening test before randomization\n* history of drug abuse, or a positive urine drug screen\n* having ETC drug or herbal medicines within 2 weeks before first administration or OTC drug or vitamin preparations within a week before first administration\n* Participation in any other clinical trial involving investigational drugs within 3 months\n* Volunteer who had whole blood donation in 2 months, or component blood donation or transfusion in 1 months\n* Regular alcohol consumption(over 21 units\u002Fweek, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study\n* Volunteers smoking over 10 cigarettes per day or who cannot abstain from smoking during the study(from 24hr before admission to discharge)\n* Volunteers who had grapefruit containing foods from 24hr before admission to discharge or who cannot abstain from grapefruit containing foods\n* Volunteers who are not using adequate contraception methods or have a pregnancy plan\n* volunteers who cannot abstain from caffeine containing foods(coffee, tea, soft drinks etc) during the study\n* any condition that, in the view of the investigator, would interfere with study participation",true,"MALE","20 Years","50 Years",{"count":63,"type":64},36,"ACTUAL","INTERVENTIONAL",[67],"PHASE1","This Phase I clinical study is to evaluate the safety and pharmacokinetics of DA-2802 319mg and Viread 300mg after a single oral dose in healthy male volunteers.",[70],"Healthy",[72],"Hepatitis B","COMPLETED","2017-04-10",{"date":76,"type":64},"2017-04-12",{"date":78,"type":64},"2015-10-06",{"date":80,"type":64},"2016-03-08",{"name":5,"class":6},1]