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

Bioequivalence of Liquid Metformin (100 mg/mL and 250 mg/mL) and Immediate-Release Metformin Tablets: A Randomized, Crossover Study in Adult Subjects

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Liquid Metformin 100 mg/mL; Drug: Liquid Metformin 250 mg/mL; Drug: Metformin Immediate-Release Tablet

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Avi Guralnik; Phone Number: 17189381157; Email: avi.berg@synergy-cro.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 tests, and 12-lead ECG, in the opinion of the investigator.

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

Able to understand and provide written informed consent prior to participation in the study.

Willing and able to comply with all study requirements, including fasting requirements and pharmacokinetic blood sampling.

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

Exclusion Criteria:

• Known hypersensitivity or contraindication to metformin or any component of the study formulations.

History 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.

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

History of lactic acidosis.

Use 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.

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

Positive urine drug screen or positive alcohol breath test at screening or admission.

Participation 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.

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

Pregnant or breastfeeding females.

Women of childbearing potential not using acceptable contraception.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single-Arm Crossover

Drug: 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 treatment period of the crossover.; 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 treatment period of the crossover.; Drug: Metformin Immediate-Release Tablet; A single oral dose of standard immediate-release metformin tablet(s) will be administered under fasting conditions in one treatment period of the crossover.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Metformin	Up to approximately 24 to 36 hours postdose in each treatment period
Maximum Observed Plasma Concentration (Cmax) of Metformin	Up to approximately 24 to 36 hours postdose in each treatment period

Collaborators and Investigators

• Sponsor: Aspargo Labs, Inc

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 28, 2026

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ASP-018-Met

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No