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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
Single oral dose of a novel liquid metformin formulation at 100 mg/mL administered under fasting conditions in one treatment period.
Single oral dose of a novel liquid metformin formulation at 250 mg/mL administered under fasting conditions in one treatment period.
Single oral dose of standard immediate-release metformin tablet(s) administered under fasting conditions in one treatment period.
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC₀-t) of Metformin
Time frame: Up to approximately 24 to 36 hours postdose in each treatment period
Maximum Observed Plasma Concentration (Cmax) of Metformin
Time frame: Up to approximately 24 to 36 hours postdose in each treatment period
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