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PK and Relative Bioavailability of Novel Liquid Metformin vs Tablets

NCT07300020 · 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, three-period crossover study evaluating the single-dose pharmacokinetics and relative bioavailability of a novel liquid metformin formulation at concentrations of 100 mg/mL and 250 mg/mL compared with immediate-release metformin tablets in healthy adult subjects. All participants will receive each formulation in randomized sequence with washout periods between treatments. Serial blood samples will be collected to characterize metformin pharmacokinetic parameters, and safety and tolerability will be assessed throughout the study.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Novel Liquid Metformin 100 mg/mL

Single oral dose of a novel liquid metformin formulation at 100 mg/mL administered under fasting conditions in one treatment period.

DRUG

Novel Liquid Metformin 250 mg/mL

Single oral dose of a novel liquid metformin formulation at 250 mg/mL administered under fasting conditions in one treatment period.

DRUG

Metformin Immediate-Release Tablet

Single oral dose of standard immediate-release metformin tablet(s) administered under fasting conditions in one treatment period.

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
2026-04-15
Primary Completion
2026-06-15
Completion
2026-06-28
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 NCT07300020 on ClinicalTrials.gov