NCT07300046

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Aspargo Labs, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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 period of the crossover to assess tolerability and safety.
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.
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.

Timeline

• Start date: 2026-06-15
• Primary completion: 2026-08-15
• Completion: 2026-08-28
• First posted: 2025-12-23
• Last updated: 2025-12-23

Regulatory

• FDA-regulated drug study