[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475425":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":44,"collaborators":46,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":26,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":26,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":77,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Darnitsa Pharmaceutical Company","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PERINDOPRES® TRIO (Test)","EXPERIMENTAL","A single oral dose of the test product PERINDOPRES® TRIO 8 mg perindopril tert-butylamine \u002F 2.5 mg indapamide \u002F 10 mg amlodipine tablets.",[13],"Drug: PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine \u002F 2.5 mg indapamide \u002F 10 mg amlodipine tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"TRIPLIXAM® 10 mg \u002F2.5 mg\u002F10 mg","ACTIVE_COMPARATOR","A single oral dose of the reference product TRIPLIXAM® 10 mg \u002F2.5 mg\u002F10 mg, 10 mg perindopril arginine \u002F 2.5 mg indapamide \u002F 10 mg amlodipine film-coated tablets.",[19],"Drug: TRIPLIXAM® 10 mg \u002F2.5 mg\u002F10 mg, 10 mg perindopril arginine \u002F 2.5 mg indapamide \u002F 10 mg amlodipine film-coated tablets",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine \u002F 2.5 mg indapamide \u002F 10 mg amlodipine tablets","Oral, generic fixed-dose combination of perindopril tert-butylamine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure), indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure) and amlodipine (calcium channel blocker used to treat high blood pressure and coronary artery disease).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"TRIPLIXAM® 10 mg \u002F2.5 mg\u002F10 mg, 10 mg perindopril arginine \u002F 2.5 mg indapamide \u002F 10 mg amlodipine film-coated tablets","Oral, innovative fixed-dose combination of perindopril arginine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure), indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure) and amlodipine (calcium channel blocker used to treat high blood pressure and coronary artery disease).",[15],[32],{"facility":33,"status":26,"city":34,"state":26,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":26},"International Pharmaceutical Research Center","Amman","11196","Jordan","JO",{"type":39,"coordinates":40},"Point",[41,42],35.94503,31.95522,{"lat":42,"lon":41},{"type":45,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[47],{"name":33,"class":48},"OTHER","100475425","phase-1-bioequivalence-study-of-8-mg-perindopril-tert-butylamine--25-mg-indapamide--10-mg-amlodipine-tablets-versus-10-mg-perindopril-arginine--25-mg-indapamide--10-mg-amlodipine-film-coated-tablets-in-healthy-volunteers-100475425",false,"NCT05470764","Bioequivalence Study of 8 mg Perindopril Tert-Butylamine \u002F 2.5 mg Indapamide \u002F 10 mg Amlodipine Tablets Versus 10 mg Perindopril Arginine \u002F 2.5 mg Indapamide \u002F 10 mg Amlodipine Film-Coated Tablets in Healthy Volunteers","Randomized, Open-label, Single-dose, Two-sequence, Two-period, Crossover, Comparative, Oral Bioequivalence Study of Test Product PERINDOPRES® TRIO, 8 mg Perindopril Tert-Butylamine \u002F 2.5 mg Indapamide\u002F 10 mg Amlodipine Tablets (PrJSC \"Pharmaceutical Firm \"Darnitsa\") And Reference Product TRIPLIXAM® 10 mg \u002F2.5 mg\u002F10 mg, 10 mg Perindopril Arginine \u002F 2.5 mg Indapamide \u002F 10 mg Amlodipine Film-Coated Tablets (Manufactured By Servier (Ireland) Industries Ltd) In Healthy, Adult Subjects Under Fasting Conditions","Inclusion Criteria:\n\nHealthy subjects, age 18 to 50 years, inclusive, body mass index (BMI) range is within 18.5 - 30.0 kg\u002Fm2, subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs, standard ECG assessment is normal (no QTc prolongation), medical history and physical examination within medically acceptable criteria, laboratory investigations tests within laboratory reference ranges (ALP and creatinine are accepted if below the reference range after being evaluated by the physician as clinically not significant). Haematology tests within 5% of reference limits.",true,"ALL","18 Years","50 Years",{"count":61,"type":62},52,"ACTUAL","INTERVENTIONAL",[65],"PHASE1","The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine \u002F 2.5 mg indapamide \u002F 10 mg amlodipine tablets manufactured by PrJSC \"Pharmaceutical firm \"Darnitsa\" \\[Ukraine\\]) and a Reference medication (marketed medicinal product TRIPLIXAM® 10 mg \u002F2.5 mg\u002F10 mg, 10 mg perindopril arginine \u002F 2.5 mg indapamide \u002F 10 mg amlodipine film-coated tablets \\[manufactured by Servier (Ireland) Industries Ltd\\]) in healthy adult volunteers under fasting conditions.",[68,69],"Bioequivalence","Healthy Subjects",[71,72,73,74,75,76],"bioequivalence","perindopril","indapamide","amlodipine","healthy subjects","pharmacokinetics","COMPLETED","2022-07-20",{"date":80,"type":62},"2022-07-22",{"date":82,"type":62},"2021-05-30",{"date":84,"type":62},"2021-06-28",{"name":5,"class":6},1]