Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT07300033
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:
Bioequivalence Study of Liquid Metformin (100 and 250 mg/mL) vs IR 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': '2026-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-07-28', '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': '2026-07-15', '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, two-treatment, two-period crossover study evaluating the bioequivalence of liquid metformin formulations at 100 mg/mL and 250 mg/mL compared with immediate-release metformin tablets in healthy adult subjects. Each participant will receive both treatments in randomized sequence with an adequate washout interval between periods. Serial blood samples will be collected to assess metformin pharmacokinetics, and safety will be monitored 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, clinical laboratory tests, and 12-lead ECG, 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.\n\nAble to understand and provide written informed consent prior to participation in the study.\n\nWilling and able to comply with all study requirements, including fasting requirements and pharmacokinetic blood sampling.\n\nFemales of childbearing potential must use an acceptable method of 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 disorder 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 abnormal clinical laboratory findings.\n\nHistory of lactic acidosis.\n\nUse of prescription or over-the-counter medications, herbal supplements, or dietary supplements within 14 days before the first study dose, 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 trial 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 or more of blood, or significant blood loss, within 8 weeks before first study dose.\n\nPregnant or breastfeeding females.\n\nWomen of childbearing potential not using acceptable contraception.\n\nAny condition or situation that, in the opinion of the investigator, would make the participant unsuitable for the study.'}, 'identificationModule': {'nctId': 'NCT07300033', 'briefTitle': 'Bioequivalence Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aspargo Labs, Inc'}, 'officialTitle': 'Bioequivalence of Liquid Metformin (100 mg/mL and 250 mg/mL) and Immediate-Release Metformin Tablets: A Randomized, Crossover Study in Adult Subjects', 'orgStudyIdInfo': {'id': 'ASP-018-Met'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-Arm Crossover', 'interventionNames': ['Drug: Liquid Metformin 100 mg/mL', 'Drug: Liquid Metformin 250 mg/mL', 'Drug: 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 treatment period of the crossover.', '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 treatment period of the crossover.', 'armGroupLabels': ['Single-Arm Crossover']}, {'name': 'Metformin Immediate-Release Tablet', 'type': 'DRUG', 'description': 'A single oral dose of standard immediate-release metformin tablet(s) will be administered under fasting conditions in one treatment period of the crossover.', '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'}}}}