Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT07300020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PK and Relative Bioavailability of Novel Liquid Metformin vs 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': '2026-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-28', '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': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Metformin', 'timeFrame': 'Up to approximately 24 to 36 hours postdose in each treatment period'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Metformin', 'timeFrame': 'Up to approximately 24 to 36 hours postdose in each treatment period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This is an open-label, randomized, three-period crossover study evaluating the single-dose pharmacokinetics and relative bioavailability of a novel liquid metformin formulation at concentrations of 100 mg/mL and 250 mg/mL compared with immediate-release metformin tablets in healthy adult subjects. All participants will receive each formulation in randomized sequence with washout periods between treatments. Serial blood samples will be collected to characterize metformin pharmacokinetic parameters, and safety and tolerability will be assessed throughout the study.'}, '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 tests, in the opinion of the investigator.\n\nNon-smoker or light smoker (10 or fewer cigarettes per day or equivalent) willing to abstain from smoking during confinement periods, as determined by the investigator.\n\nAble to understand and provide written informed consent before any study-specific procedures are performed.\n\nWilling and able to comply with all study requirements, including fasting requirements, visit schedules, and pharmacokinetic blood sampling.\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 component of the study formulations.\n\nHistory or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disease that, in the opinion of the investigator, could interfere with study participation or interpretation of results.\n\nEstimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m², or any clinically significant abnormality in clinical laboratory tests.\n\nHistory of lactic acidosis.\n\nUse of any prescription or over-the-counter medications, herbal products, or dietary supplements within 14 days before the first study dose, unless considered acceptable 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 admission to the clinical unit.\n\nParticipation in another clinical trial or receipt of an investigational drug or device within 30 days or 5 half-lives of the prior investigational product (whichever is longer) before the first study dose.\n\nDonation of 450 mL or more 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 methods of contraception.\n\nAny condition or circumstance that, in the opinion of the investigator, would make the subject unsuitable for the study.'}, 'identificationModule': {'nctId': 'NCT07300020', 'briefTitle': 'PK and Relative Bioavailability of Novel Liquid Metformin vs Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aspargo Labs, Inc'}, 'officialTitle': 'Single-Dose Pharmacokinetics and Relative Bioavailability of a Novel Liquid Metformin Formulation (100 mg/mL and 250 mg/mL) Compared With Immediate-Release Metformin Tablets in Adult Subjects', 'orgStudyIdInfo': {'id': 'ASP-017-Met'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-Arm Crossover', 'interventionNames': ['Drug: Novel Liquid Metformin 100 mg/mL', 'Drug: Novel Liquid Metformin 250 mg/mL', 'Drug: Metformin Immediate-Release Tablet']}], 'interventions': [{'name': 'Novel Liquid Metformin 100 mg/mL', 'type': 'DRUG', 'description': 'Single oral dose of a novel liquid metformin formulation at 100 mg/mL administered under fasting conditions in one treatment period.', 'armGroupLabels': ['Single-Arm Crossover']}, {'name': 'Novel Liquid Metformin 250 mg/mL', 'type': 'DRUG', 'description': 'Single oral dose of a novel liquid metformin formulation at 250 mg/mL administered under fasting conditions in one treatment period.', 'armGroupLabels': ['Single-Arm Crossover']}, {'name': 'Metformin Immediate-Release Tablet', 'type': 'DRUG', 'description': 'Single oral dose of standard immediate-release metformin tablet(s) administered under fasting conditions in one treatment period.', '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'}}}}