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

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

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

Treatments tested in this trial

  • Liquid Metformin 100 mg/mL
  • Liquid Metformin 250 mg/mL
  • Metformin Immediate-Release Tablet

Treatment groups

24 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators