[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100433019":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":50,"locations":60,"responsibleParty":109,"collaborators":111,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":55,"eligibilityCriteria":124,"healthyVolunteers":125,"sex":126,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":55,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":142,"whyStopped":55,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"EuroPharma, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Berberine MetX™ Ultra Absorption","EXPERIMENTAL","16 healthy subjects will receive orally 500 mg of berberine in two capsules of Berberine MetX™ Ultra Absorption.",[13],"Combination Product: Berberine incorporated in gamma cyclodextrin",{"label":15,"type":16,"description":17,"interventionNames":18},"Berberine MetX™","ACTIVE_COMPARATOR","16 healthy subjects will receive orally 500 mg of berberine in one capsule of Berberine MetX™ (reference product).",[19],"Dietary Supplement: Berberine",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Berberine incorporated in gamma cyclodextrin","Experimental modified product. One capsule contains 250 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract incorporated in gamma-cyclodextrin",[9],[27],"Berberine MetX™ Ultra Absorption, 250 mg",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DIETARY_SUPPLEMENT","Berberine","Active comparator. One capsule contains 500 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract",[15],[34],"Berberine MetX™, 500 mg",[36,40,43,46],{"name":37,"affiliation":38,"role":39},"Aghavni Ginosyan, PhD, MD","Scientific Center of Drug and Medical Technologies Expertise of the Ministry of Health, Armenia","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":39},"Samvel Hairumyan, PhD, MD","CARDIOMED Family Health Center, LLC of the Ministry of Health of the Republic of Armenia",{"name":44,"affiliation":45,"role":39},"Areg Hovhannisyan, PhD","Institute of Fine Organic Chemistry of the National Academy of Science, Armenia",{"name":47,"affiliation":48,"role":49},"Alexander G Panossian, PhD","Phytomed AB, Sweden","STUDY_DIRECTOR",[51,57],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Alexander G. Panossian, PhD","CONTACT","+46733306226",null,"ap@phytomed.se",{"name":58,"role":53,"phone":55,"phoneExt":55,"email":59},"Jennifer Hansgate","jhansgate@europharmausa.com",[61,75,85,94],{"facility":42,"status":55,"city":62,"state":55,"zip":55,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Yerevan","Armenia","AM",{"type":66,"coordinates":67},"Point",[68,69],44.5126,40.17765,{"lat":69,"lon":68},[72],{"name":41,"role":53,"phone":73,"phoneExt":55,"email":74},"+37493203057","hsamvel@mail.ru",{"facility":76,"status":55,"city":62,"state":55,"zip":55,"country":63,"countryCode":64,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Institute of Fine Organic Chemistry of the National Academy of Science",{"type":66,"coordinates":78},[68,69],{"lat":69,"lon":68},[81],{"name":82,"role":53,"phone":83,"phoneExt":55,"email":84},"Areg Hovhannisyan, PhD Areg Hovhannisyan, PhD, PhD","+37494282018","areglab@mail.ru",{"facility":86,"status":55,"city":62,"state":55,"zip":55,"country":63,"countryCode":64,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"Scientific Center of Drug and Medical Technologies Expertise",{"type":66,"coordinates":88},[68,69],{"lat":69,"lon":68},[91],{"name":37,"role":53,"phone":92,"phoneExt":55,"email":93},"+37493360653","aghavni_ginosian@yahoo.com",{"facility":95,"status":55,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Phytomed AB","Våxtorp","HL","31275","Sweden","SE",{"type":66,"coordinates":102},[103,104],13.12008,56.41678,{"lat":104,"lon":103},[107],{"name":108,"role":53,"phone":54,"phoneExt":55,"email":56},"Alexander G.",{"type":110,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR",[112,114,116,117],{"name":38,"class":113},"UNKNOWN",{"name":115,"class":113},"Cardiomed LLC, Armenia",{"name":45,"class":113},{"name":48,"class":113},"100433019","phase-1-effect-of-gamma-cyclodextrin-on-the-bioavailability-of-berberine-100433019",false,"NCT04918667","Effect of Gamma-cyclodextrin on the Bioavailability of Berberine","A Phase I, Randomized, Crossover, Double-blind, Pharmacokinetic Study of Berberine Released From Cyclodextrin in Healthy Volunteers","Inclusion Criteria:\n\n* Healthy volunteers, as determined by medical history, physical examination, and clinical laboratory testing,\n* Willingness to stay in the unit overnight for the duration of the study,\n* Provide a signed written informed consent.\n\nExclusion Criteria:\n\n* overweight (BMI \\>35 kg\u002Fm2),\n* pregnancy,\n* lactation,\n* drug abuse,\n* use of dietary supplements or any form of medication (with the exception of oral contraceptives),\n* heavy smokers, or ex-smokers with a remote history (\\> one pack\u002Fday),\n* frequent alcohol consumption (\\>20 g ethanol\u002Fd),\n* adherence to a restrictive dietary regimen,\n* physical activity of more than 5 h\u002Fwk,\n* respiratory tract infections, or suspicion thereof in the last 14 days before dosing,\n* history or presence of disease in the kidneys and heart, lungs, liver, gastrointestinal tract, endocrine organs or other conditions such as metabolic disease known to interfere with the absorption, distribution, metabolism, and excretion of drugs,\n* malignancy,\n* autoimmune disorders such as (but not limited to) lupus erythematosus, multiple sclerosis, rheumatoid arthritis, or sarcoidosis,\n* any other disease or condition, which, in the opinion of the Investigator, would make the subject unsuitable for this study,\n* currently taking medications known to be CYP2C9 inducers (i.e., carbamazepine and rifampicin).",true,"ALL","18 Years","60 Years",{"count":130,"type":131},16,"ESTIMATED","INTERVENTIONAL",[134],"PHASE1","In this study, we will evaluate the relative bioavailability of Berberine (BB) from capsules containing Indian Barberry (Berberis aristate DC.) Bark and Root Extract in the blood plasma of healthy subjects after oral administration of:\n\nA. Capsules containing Berberine and GCD (BBA Berberine MetX™ Ultra Absorption, 250 mg) B. Capsules containing Berberine (BB, Berberine MetX™, 500 mg) - (reference product).",[137],"Drug Absorption",[30,139,140,141,9],"gamma-cyclodextrin","Pharmacokinetic","Bioavailability","NOT_YET_RECRUITING","2023-09-12",{"date":145,"type":146},"2023-09-14","ACTUAL",{"date":148,"type":131},"2024-09",{"date":150,"type":131},"2026-12",{"name":5,"class":6},4]