Tolerability Study of Liquid Metformin (100 and 250 mg/mL) vs IR 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 tolerability 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. Each participant will receive single oral doses of study treatments in a randomized sequence. Safety and tolerability will be assessed through adverse event monitoring, gastrointestinal symptom evaluations, vital signs, clinical laboratory tests, and ECGs.

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 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 tolerability 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 tolerability and safety.
Standard Metformin Immediate-Release Tablet
Drug
A single oral dose of standard immediate-release metformin tablet(s) will be administered under fasting conditions in one period of the crossover to assess tolerability and safety.

Treatment groups

24 Participants

are divided into 1 treatment group

Group A: Single-Arm CrossoverExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Incidence of Gastrointestinal Treatment-Emergent Adverse Events (GI TEAEs)

Time frame

From each study dose through 24 hours postdose in each treatment period

Severity of Gastrointestinal Treatment-Emergent Adverse Events

Time frame

From each study dose through 24 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

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