Bioequivalence Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets
ConditionHealthy Volunteer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAspargo Labs, Inc
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.
Male or female adults 18 to 55 years of age, inclusive.
Known hypersensitivity or contraindication to metformin or any component of the study formulations.