[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616007":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":11,"centralContacts":25,"locations":11,"responsibleParty":31,"collaborators":11,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":11,"eligibilityCriteria":39,"healthyVolunteers":40,"sex":41,"minAge":42,"maxAge":43,"enrollmentInfo":44,"targetDuration":11,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":11,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":11},{"fullName":5,"class":6},"Aspargo Labs, Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-Arm Crossover","EXPERIMENTAL",null,[13,14],"Drug: Liquid Metformin 100 mg\u002FmL","Drug: Liquid Metformin 250 mg\u002FmL",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":11},"DRUG","Liquid Metformin 100 mg\u002FmL","A single oral dose of liquid metformin at a concentration of 100 mg\u002FmL will be administered under fasting conditions in one treatment period of the crossover.",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"Liquid Metformin 250 mg\u002FmL","A single oral dose of liquid metformin at a concentration of 250 mg\u002FmL will be administered under fasting conditions in one treatment period of the crossover.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Guralnik","CONTACT","17189381157","avi.berg@synergy-cro.com",{"type":32,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100616007","phase-1-pk-and-relative-bioavailability-of-liquid-metformin-vs-tablets-in-healthy-adults-100616007",false,"NCT07300007","PK and Relative Bioavailability of Liquid Metformin vs Tablets in Healthy Adults","An Open-Label, Randomized, Crossover Study to Characterize the Pharmacokinetics and Relative Bioavailability of Liquid Metformin at 100 mg\u002FmL and 250 mg\u002FmL Compared With Standard Metformin Tablets","Inclusion Criteria:\n\n* Male or female adults 18 to 55 years of age, inclusive.\n\nBody mass index (BMI) between 18.0 and 30.0 kg\u002Fm², inclusive.\n\nMedically healthy with no clinically significant findings on medical history, physical examination, vital signs, 12-lead ECG, or clinical laboratory tests, in the opinion of the investigator.\n\nNon-smokers or light smokers (10 or fewer cigarettes per day or equivalent) willing to abstain from smoking during confinement.\n\nAble to understand and provide written informed consent before any study procedures are conducted.\n\nWilling and able to comply with all study requirements, including fasting restrictions and visit schedules.\n\nFemales of childbearing potential must use acceptable contraception as determined by the investigator.\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.\n\nHistory or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disorders that could affect study participation or data interpretation.\n\nEstimated glomerular filtration rate (eGFR) less than 90 mL per minute per 1.73 square meters, or any clinically significant abnormal laboratory findings.\n\nHistory of lactic acidosis.\n\nUse of prescription medications, over-the-counter medications, herbal supplements, or dietary supplements within 14 days before first dosing, unless approved by the investigator.\n\nPositive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.\n\nPositive urine drug test or positive alcohol breath test at screening or admission.\n\nParticipation in another clinical trial or receipt of an investigational product within 30 days or 5 half-lives (whichever is longer) before first study dose.\n\nBlood donation of more than 450 mL or significant blood loss within 8 weeks before first dosing.\n\nPregnant or breastfeeding females.\n\nWomen of childbearing potential not using acceptable contraception.\n\nAny condition that, in the opinion of the investigator, would make the participant unsuitable for the study.",true,"ALL","18 Years","55 Years",{"count":45,"type":46},24,"ESTIMATED","INTERVENTIONAL",[49],"PHASE1","The study will evaluate the pharmacokinetics and relative bioavailability of two liquid metformin formulations (100 mg\u002FmL and 250 mg\u002FmL)",[52],"Healthy Volunteer","NOT_YET_RECRUITING","2025-12-10",{"date":56,"type":57},"2025-12-23","ACTUAL",{"date":59,"type":46},"2026-03-15",{"date":61,"type":46},"2026-05-28",{"name":5,"class":6}]