PK and Relative Bioavailability of Liquid Metformin vs Tablets in Healthy Adults

NCT07300007 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: ASP-016-MET
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will evaluate the pharmacokinetics and relative bioavailability of two liquid metformin formulations (100 mg/mL and 250 mg/mL)

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax)

  Up to approximately 24 to 36 hours postdose in each treatment period

• Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t)

  Up to approximately 24 to 36 hours postdose in each treatment period

Study Arms (1)

Single-Arm Crossover

EXPERIMENTAL

Drug: Liquid Metformin 100 mg/mL; Drug: Liquid Metformin 250 mg/mL

Interventions

Liquid Metformin 100 mg/mL DRUG

A single oral dose of liquid metformin at a concentration of 100 mg/mL will be administered under fasting conditions in one treatment period of the crossover.

Single-Arm Crossover

Liquid Metformin 250 mg/mL DRUG

A single oral dose of liquid metformin at a concentration of 250 mg/mL will be administered under fasting conditions in one treatment period of the crossover.

Single-Arm Crossover

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 with no clinically significant findings on medical history, physical examination, vital signs, 12-lead ECG, or clinical laboratory tests, in the opinion of the investigator.
• Non-smokers or light smokers (10 or fewer cigarettes per day or equivalent) willing to abstain from smoking during confinement.
• Able to understand and provide written informed consent before any study procedures are conducted.
• Willing and able to comply with all study requirements, including fasting restrictions and visit schedules.
• Females of childbearing potential must use acceptable contraception as determined by the investigator.

You may not qualify if:

• Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.
• History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or psychiatric disorders that could affect study participation or data interpretation.
• Estimated glomerular filtration rate (eGFR) less than 90 mL per minute per 1.73 square meters, or any clinically significant abnormal laboratory findings.
• History of lactic acidosis.
• Use of prescription medications, over-the-counter medications, herbal supplements, or dietary supplements within 14 days before first dosing, unless approved by the investigator.
• Positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV.
• Positive urine drug test 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 first study dose.
• Blood donation of more than 450 mL or significant blood loss within 8 weeks before first dosing.
• Pregnant or breastfeeding females.
• Women of childbearing potential not using acceptable contraception.
• Any condition that, in the opinion of the investigator, would make the participant unsuitable for the study.

Sponsors & Collaborators

• Aspargo Labs, Inc: lead

Central Study Contacts

Guralnik

CONTACT

17189381157; avi.berg@synergy-cro.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-arm, three-period, three-treatment crossover study in which all participants receive each metformin formulation in randomized sequence.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: March 15, 2026
• Primary Completion: May 15, 2026
• Study Completion: May 28, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share