NCT07300033

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

• 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, 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.

Conditions

• Healthy Volunteer

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 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.

Timeline

• Start date: 2026-05-15
• Primary completion: 2026-07-15
• Completion: 2026-07-28
• First posted: 2025-12-23
• Last updated: 2025-12-23

Regulatory

• FDA-regulated drug study