[{"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:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"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":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Healthy Volunteers","NOT_YET_RECRUITING","2026-06-23",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":32,"type":22},{"date":36,"type":22},"2026-08-27",{"name":38,"class":39},"Keri Pharma Hungary Kft","INDUSTRY",""]