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Tolerability Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets
Sponsor: Aspargo Labs, Inc
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.
Official title: A Randomized Study to Assess the Tolerability Profile of Two Concentrations of Liquid Metformin (100 mg/mL and 250 mg/mL) Compared With Standard Metformin Tablets
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-06-15
Completion Date
2026-08-28
Last Updated
2025-12-23
Healthy Volunteers
Yes
Conditions
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.
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.
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.