[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616010":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":11,"centralContacts":30,"locations":11,"responsibleParty":36,"collaborators":11,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":11,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":11,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":11},{"fullName":5,"class":6},"Aspargo Labs, Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-Arm Crossover","EXPERIMENTAL",null,[13,14,15],"Drug: Liquid Metformin 100 mg\u002FmL","Drug: Liquid Metformin 250 mg\u002FmL","Drug: Standard Metformin Immediate-Release Tablet",[17,22,26],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"DRUG","Liquid Metformin 100 mg\u002FmL","A single oral dose of a liquid metformin formulation at a concentration of 100 mg\u002FmL will be administered under fasting conditions in one period of the crossover to assess tolerability and safety.",[9],{"type":18,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"Liquid Metformin 250 mg\u002FmL","A single oral dose of a liquid metformin formulation at a concentration of 250 mg\u002FmL will be administered under fasting conditions in one period of the crossover to assess tolerability and safety.",[9],{"type":18,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Standard Metformin Immediate-Release Tablet","A single oral dose of standard immediate-release metformin tablet(s) will be administered under fasting conditions in one period of the crossover to assess tolerability and safety.",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},"Avi Guralnik","CONTACT","17189381157","avi.berg@synergy-cro.com",{"type":37,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100616010","phase-1-tolerability-study-of-liquid-metformin-100-and-250-mgml-vs-ir-tablets-100616010",false,"NCT07300046","Tolerability Study of Liquid Metformin (100 and 250 mg\u002FmL) vs IR Tablets","A Randomized Study to Assess the Tolerability Profile of Two Concentrations of Liquid Metformin (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 based on medical history, physical examination, vital signs, clinical laboratory evaluations, and 12-lead ECG, in the opinion of the investigator.\n\nNon-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during study confinement periods.\n\nAble to provide written informed consent before any study-specific procedures are conducted.\n\nWilling and able to comply with all study requirements, including fasting, dosing restrictions, and safety\u002Ftolerability assessments.\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, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disease that, in the investigator's opinion, could interfere with participation or data interpretation.\n\nEstimated glomerular filtration rate (eGFR) \\\u003C 90 mL\u002Fmin\u002F1.73 m², or any clinically significant abnormal clinical laboratory findings.\n\nPrior history of lactic acidosis.\n\nCurrent or recent (within 14 days before first dose) use of prescription drugs, over-the-counter medications, herbal products, or dietary supplements, unless approved by the investigator.\n\nPositive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.\n\nPositive urine drug screen or positive alcohol breath test at screening or at check-in.\n\nParticipation in another clinical trial or receipt of an investigational drug or device within 30 days or 5 half-lives (whichever is longer) before first study dose.\n\nDonation of ≥450 mL of blood, or significant blood loss, within 8 weeks before the first study dose.\n\nPregnant or breastfeeding females.\n\nWomen of childbearing potential not using acceptable contraception.\n\nAny condition or finding that, in the opinion of the investigator, would make the subject unsuitable for the study.",true,"ALL","18 Years","55 Years",{"count":50,"type":51},24,"ESTIMATED","INTERVENTIONAL",[54],"PHASE1","This is an open-label, randomized study evaluating the tolerability of two concentrations of liquid metformin formulations (100 mg\u002FmL and 250 mg\u002FmL) compared with standard immediate-release metformin tablets in healthy adult subjects. Each participant will receive single oral doses of study treatments in a randomized sequence. Safety and tolerability will be assessed through adverse event monitoring, gastrointestinal symptom evaluations, vital signs, clinical laboratory tests, and ECGs.",[57],"Healthy Volunteers","NOT_YET_RECRUITING","2025-12-10",{"date":61,"type":62},"2025-12-23","ACTUAL",{"date":64,"type":51},"2026-06-15",{"date":66,"type":51},"2026-08-28",{"name":5,"class":6}]