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
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 groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov