PK and Relative Bioavailability of Novel Liquid Metformin vs 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, 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

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

  • Novel Liquid Metformin 100 mg/mL
  • Novel 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