Short-Term Glycemic Effects of Liquid Metformin vs Standard Tablets

ConditionHealthy Volunteers

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 study evaluating the short-term glycemic effects 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. Participants will receive single or short-term doses of study treatments in a randomized sequence. Blood glucose measurements and other glycemic indicators will be collected to assess short-term pharmacodynamic effects. Safety and tolerability will also be monitored.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Known hypersensitivity or contraindication to metformin or any excipients in 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 period of the crossover to assess short-term glycemic effects and safety.
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 period of the crossover to assess short-term glycemic effects and safety.
Standard Metformin Immediate-Release Tablet
Drug
A single oral dose of standard metformin immediate-release tablet(s) will be administered under fasting conditions in one period of the crossover to assess short-term glycemic effects and safety.

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 Blood Glucose-Time Curve from 0 to 4 Hours Postdose (Glucose AUC₀-₄h)

Time frame

0 to 4 hours after each study dose 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

This trial is not recruiting at the moment. You can still explore other options: