[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Keri Pharma Hungary Kft\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100644692","phase-1-dimotec-diosmin-1000-mg-film-coated-tablet-fed-study-100644692",false,"NCT07674446","Dimotec (Diosmin) 1000 mg Film Coated Tablet Fed Study","Comparative Bioavailability Study of Dimotec 1000 mg Film-coated Tablet Versus Detralex 1000 mg Film Coated Tablets in Healthy Subjects Under Fed Conditions: Randomized, Four-period, Full-replicate Crossover","Diosmin","Inclusion Criteria:\n\n* Healthy adult human participants aged 18 to 55 years (inclusive)\n* BMI between 18.50 and 30.00 kg\u002Fm2 (inclusive), capable of giving informed consent\n* Normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests during screening within 28 days of enrollment\n* Normal 12-lead electrocardiogram (ECG)\n* Normal chest X-Ray (P\u002FA view) taken not more than 180 days prior to check-in of Period 1\n* Non-smoker or ex-smoker who stopped smoking at least 6 months before first dosing\n* Non-alcoholic\n* Female participants of childbearing potential must practice a medically acceptable method of contraception (double barrier, IUD, or abstinence); females with no childbearing potential defined as surgically sterile or post-menopausal for at least 1 year\n\nExclusion Criteria:\n\n* Contraindications or hypersensitivity to the study drug, related drug group, or excipients\n* History or presence of significant asthma, urticaria, seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological, psychiatric, endocrine, immunological, hematopoietic, diarrheal, or ongoing infectious diseases, or any other significant abnormality\n* History or presence of gastrointestinal inflammation, bleeding, ulceration, hemorrhage, or perforation of the stomach, small intestine, or large intestine\n* History of dermatological diseases (skin reactions, skin rash) related to drug use, or presence of any dermatological diseases\n* Unable to swallow large-size tablets\n* Use of any food supplements containing flavonoids within 14 days before first dosing or during the study\n* Blood donation (500 mL) or participation in any clinical study within 90 days prior to check-in\n* Use of any prescribed medications, OTC medications, or herbal medications within 30 days prior to first dose\n* Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids, barbiturates) in urine at check-in\n* Positive urine\u002Fbreath alcohol test at check-in\n* Positive pregnancy test\n* Currently pregnant, breast-feeding, or likely to become pregnant during the study\n* Use of implanted or injected hormonal contraceptives within 6 months prior to study, or hormonal contraceptives within 14 days before dosing",true,"ALL","18 Years","55 Years",{"count":22,"type":23},72,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This study aims to compare the bioavailability of Dimotec 1000 mg film-coated tablet (Test; Keri Pharma Hungary Kft.) with Detralex 1000 mg film-coated tablets (Reference; Les Laboratoires Servier Industrie, France) in healthy adult human participants under fed conditions. The study will also evaluate the safety and tolerability of a single dose of the investigational products.",[29],"Healthy Volunteers","NOT_YET_RECRUITING","2026-06-23",{"date":33,"type":34},"2026-06-29","ACTUAL",{"date":33,"type":23},{"date":37,"type":23},"2026-08-27",{"name":39,"class":40},"Keri Pharma Hungary Kft","INDUSTRY",""]