This is an open-label assessment of the bioequivalence of two 500 mg-tablet formulations of imeglimin (Tablet A \[reference product\] and Tablet B \[test product\]), in at least 16 healthy Caucasian volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Reference product
Test product (new formulation tablet)
Hammersmith Medicines Research (HMR)
London, United Kingdom
Pk parameters of imeglimin
Cmax: peak plasma concentration after dosing
Time frame: from dosing up to 48h
PK parameters of Imeglimin
AUC last: area Under the concentration time curve
Time frame: from dosing up to 48h
Incidence of treatment emergent adverse events (Safety and tolerability)
Incidence of treatment emergent adverse events
Time frame: From Day 1 to Day 15
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