This is an open-label, randomized study evaluating the tolerability of two concentrations of liquid metformin formulations (100 mg/mL and 250 mg/mL) compared with standard immediate-release metformin tablets in healthy adult subjects. Each participant will receive single oral doses of study treatments in a randomized sequence. Safety and tolerability will be assessed through adverse event monitoring, gastrointestinal symptom evaluations, vital signs, clinical laboratory tests, and ECGs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
24
A single oral dose of a liquid metformin formulation at a concentration of 100 mg/mL will be administered under fasting conditions in one period of the crossover to assess tolerability and safety.
A single oral dose of a liquid metformin formulation at a concentration of 250 mg/mL will be administered under fasting conditions in one period of the crossover to assess tolerability and safety.
A single oral dose of standard immediate-release metformin tablet(s) will be administered under fasting conditions in one period of the crossover to assess tolerability and safety.
Incidence of Gastrointestinal Treatment-Emergent Adverse Events (GI TEAEs)
Time frame: From each study dose through 24 hours postdose in each treatment period
Severity of Gastrointestinal Treatment-Emergent Adverse Events
Time frame: From each study dose through 24 hours postdose in each treatment period
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