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

ConditionHealthy Volunteer

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorAspargo Labs, Inc

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female adults 18 to 55 years of age, inclusive.

Disqualifiers

Known hypersensitivity or contraindication to metformin or any component of the study formulations.

Trial design

Design model

Crossover

Treatments tested in this trial

Liquid Metformin 100 mg/mL
Drug
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.
Liquid Metformin 250 mg/mL
Drug
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.
Metformin Immediate-Release Tablet
Drug
A single oral dose of standard immediate-release metformin tablet(s) will be administered under fasting conditions in one treatment period of the crossover.

Treatment groups

24 Participants

are divided into 1 treatment group

Group A: Single-Arm CrossoverExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Metformin

Time frame

Up to approximately 24 to 36 hours postdose in each treatment period

Maximum Observed Plasma Concentration (Cmax) of Metformin

Time frame

Up to approximately 24 to 36 hours postdose in each treatment period

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aspargo Labs, Inc

Lead sponsor

Source ClinicalTrials.gov

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