Tolerability Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets

Aspargo Labs, Inc

Status and phase

Begins enrollment in 4 months

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Liquid Metformin 100 mg/mL

Drug: Standard Metformin Immediate-Release Tablet

Drug: Liquid Metformin 250 mg/mL

Study type

Interventional

Funder types

Industry

Identifiers

NCT07300046

ASP-019-Met

Details and patient eligibility

About

This is an open-label, randomized study evaluating the tolerability 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. 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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female adults 18 to 55 years of age, inclusive.

Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive.

Medically healthy based on medical history, physical examination, vital signs, clinical laboratory evaluations, and 12-lead ECG, in the opinion of the investigator.

Non-smoker or light smoker (10 cigarettes per day or fewer, or equivalent) willing to abstain during study confinement periods.

Able to provide written informed consent before any study-specific procedures are conducted.

Willing and able to comply with all study requirements, including fasting, dosing restrictions, and safety/tolerability assessments.

Females of childbearing potential must use acceptable contraception as determined by the investigator.

Exclusion criteria

Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.

History 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.

Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m², or any clinically significant abnormal clinical laboratory findings.

Prior history of lactic acidosis.

Current 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.

Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.

Positive urine drug screen or positive alcohol breath test at screening or at check-in.

Participation 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.

Donation of ≥450 mL of blood, or significant blood loss, within 8 weeks before the first study dose.

Pregnant or breastfeeding females.

Women of childbearing potential not using acceptable contraception.

Any condition or finding that, in the opinion of the investigator, would make the subject unsuitable for the study.