[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100149911":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":25,"responsibleParty":38,"collaborators":41,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":24,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":24,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":24,"overallStatus":64,"whyStopped":24,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"sigma-tau i.f.r. S.p.A.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"fed treatment","EXPERIMENTAL","18 healthy volunteers administered with a single dose of Eurartesim",[13],"Drug: Eurartesim",{"label":15,"type":10,"description":16,"interventionNames":17},"Fasted Treatment","18 healthy volunteers treated with a single dose of Eurartesim",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Eurartesim","Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 4 Tablets a Day for body weight above 75 kg.",[15,9],null,[26],{"facility":27,"status":24,"city":28,"state":24,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":24},"CMAX, a division of IDT Australia Limited","Adelaide","SA 5000","Australia","AU",{"type":33,"coordinates":34},"Point",[35,36],138.59863,-34.92866,{"lat":36,"lon":35},{"type":24,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":39,"oldOrganization":40},"Giovanni Valentini, MD","Medical Department, R&D Division, Sigma-Tau ifr SpA",[42],{"name":43,"class":6},"CPR Pharma Services Pty Ltd, Australia","100149911","phase-1-food-interaction-study-on-the-pharmacokinetics-of-eurartesim-dha-and-pqpin-healthy-male-adult-volunteers-100149911",false,"NCT01222962","Food Interaction Study on the Pharmacokinetics of Eurartesim™ (DHA and PQP)in Healthy Male Adult Volunteers","Study of the Effect of Food on the Pharmacokinetics of DHA and PQP After Single Oral Administration of Eurartesim™ in Healthy Male Adult Volunteers","Inclusion Criteria:\n\n* Caucasian healthy males aged between 18 and 50 years(inclusive).\n* Body Mass Index (BMI) between 19.0 kg\u002Fm2 and 27.0 kg\u002Fm2 inclusive, with a minimum body weight of 75 kg.\n* Agreed to use two approved methods of contraception from Screening and until 90 days after administration of the study drug\n* Had given written informed consent to participate in this study in accordance with local regulations.\n\nExclusion Criteria:\n\n* Had received or was anticipated to receive a prescription medication within 14 days prior to the start of dosing or an over-the-counter medicine 48 hours prior to the start of dosing.\n* Abnormal laboratory test results deemed clinically significant by the Medical Officer.\n* Positive urine drug test (e.g. opiates and cannabinoids) or alcohol breath test.\n* History of significant drug allergies or significant allergic reaction.\n* Receipt of blood or blood products, or loss or donation of 450 mL or more of blood within 90 days before the first dose administration.",true,"MALE","18 Years","50 Years",{"count":56,"type":57},37,"ACTUAL","INTERVENTIONAL",[60],"PHASE1","The study was designed to assess the effect of food on the extent and rate of absorption of Dihydroartemisinin (DHA) and Piperaquine Phosphate (PQP) administered as a fixed dose combination (Eurartesim™).",[63],"Malaria, Falciparum","COMPLETED","2010-10-14",{"date":67,"type":68},"2010-10-18","ESTIMATED",{"date":70,"type":24},"2010-03",{"date":72,"type":57},"2010-06",{"name":5,"class":6},1]