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

NCT ID: NCT07300046

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-15
• Study Completion Date: 2026-08-28

Brief Summary

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single-Arm Crossover

Group Type: EXPERIMENTAL

Liquid Metformin 100 mg/mL

Intervention Type: DRUG

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 tolerability and safety.

Liquid Metformin 250 mg/mL

Intervention Type: DRUG

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 tolerability and safety.

Standard Metformin Immediate-Release Tablet

Intervention Type: DRUG

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.

Interventions

Liquid Metformin 100 mg/mL

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 tolerability and safety.

Intervention Type: DRUG

Liquid Metformin 250 mg/mL

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 tolerability and safety.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aspargo Labs, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Avi Guralnik

Role: CONTACT

Phone: 17189381157

Email: avi.berg@synergy-cro.com

Other Identifiers

ASP-019-Met

Identifier Type: -

Identifier Source: org_study_id