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NOT YET RECRUITING
NCT07300046
PHASE1

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

Sponsor: Aspargo Labs, Inc

View on ClinicalTrials.gov

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

Interventions

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.