PK and Relative Bioavailability of Novel Liquid Metformin vs 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, 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.

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

Novel Liquid Metformin 100 mg/mL
Drug
Single oral dose of a novel liquid metformin formulation at 100 mg/mL administered under fasting conditions in one treatment period.
Novel Liquid Metformin 250 mg/mL
Drug
Single oral dose of a novel liquid metformin formulation at 250 mg/mL administered under fasting conditions in one treatment period.
Metformin Immediate-Release Tablet
Drug
Single oral dose of standard immediate-release metformin tablet(s) administered under fasting conditions in one treatment period.

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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