Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-25 @ 11:52 PM
Study NCT ID:
NCT07300059
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-Term Glycemic Effects of Liquid Metformin vs Standard Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Blood Glucose-Time Curve from 0 to 4 Hours Postdose (Glucose AUC₀-₄h)', 'timeFrame': '0 to 4 hours after each study dose in each treatment period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is an open-label, randomized study evaluating the short-term glycemic effects of two concentrations of liquid metformin formulations (100 mg/mL and 250 mg/mL) compared with standard immediate-release metformin tablets in healthy adult subjects. Participants will receive single or short-term doses of study treatments in a randomized sequence. Blood glucose measurements and other glycemic indicators will be collected to assess short-term pharmacodynamic effects. Safety and tolerability will also be monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "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/m², inclusive.\n\nMedically healthy based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations, in the opinion of the investigator.\n\nFasting blood glucose within the normal reference range at screening.\n\nNon-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during each study confinement period.\n\nAble to understand and provide written informed consent before participation.\n\nWilling and able to comply with all study procedures, including fasting requirements, glycemic assessments, and timed blood draws.\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 any clinically significant cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric condition that, in the investigator's judgment, could interfere with study participation or data interpretation.\n\nFasting blood glucose outside the normal reference range at screening, or any history of hypoglycemia or glucose regulation disorders.\n\nEstimated glomerular filtration rate (eGFR) \\< 90 mL/min/1.73 m² or any clinically significant abnormal clinical laboratory results.\n\nHistory of lactic acidosis.\n\nUse of prescription medications, over-the-counter medications, vitamins, herbal supplements, or dietary supplements within 14 days before first study dosing, 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 admission.\n\nParticipation in another clinical study or receipt of an investigational product within 30 days or 5 half-lives (whichever is longer) before the 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 that, in the opinion of the investigator, would make the participant unsuitable for the study."}, 'identificationModule': {'nctId': 'NCT07300059', 'briefTitle': 'Short-Term Glycemic Effects of Liquid Metformin vs Standard Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aspargo Labs, Inc'}, 'officialTitle': 'Short-Term Glycemic Effects of Two Concentrations of Liquid Metformin Versus Standard Metformin Tablets in Healthy Adults', 'orgStudyIdInfo': {'id': 'ASP-020-Met'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-Arm Crossover', 'interventionNames': ['Drug: Liquid Metformin 100 mg/mL', 'Drug: Liquid Metformin 250 mg/mL', 'Drug: Standard Metformin Immediate-Release Tablet']}], 'interventions': [{'name': 'Liquid Metformin 100 mg/mL', 'type': 'DRUG', 'description': 'A single oral dose of a liquid metformin formulation at a concentration of 100 mg/mL will be administered under fasting conditions in one period of the crossover to assess short-term glycemic effects and safety.', 'armGroupLabels': ['Single-Arm Crossover']}, {'name': 'Liquid Metformin 250 mg/mL', 'type': 'DRUG', 'description': 'A single oral dose of a liquid metformin formulation at a concentration of 250 mg/mL will be administered under fasting conditions in one period of the crossover to assess short-term glycemic effects and safety.', 'armGroupLabels': ['Single-Arm Crossover']}, {'name': 'Standard Metformin Immediate-Release Tablet', 'type': 'DRUG', 'description': 'A single oral dose of standard metformin immediate-release tablet(s) will be administered under fasting conditions in one period of the crossover to assess short-term glycemic effects and safety.', 'armGroupLabels': ['Single-Arm Crossover']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Avi Guralnik', 'role': 'CONTACT', 'email': 'avi.berg@synergy-cro.com', 'phone': '17189381157'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aspargo Labs, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}