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

NCT07300033 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Aspargo Labs, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2026-07-15
Completion
2026-07-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07300033 on ClinicalTrials.gov