Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Long Merck )
Study to evaluate the bioequivalence of orally administered metformin preparations, Extended release tablets, 750 mg in normal healthy subjects under fasting and fed conditions
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
First aIntervention Period: Single administered dose of Metformin (750 mg tablet extended-release) in a fasting condition
Second Intervention Period: Single administered dose of Glucophage® (750 mg tablet extended-release) in a fasting condition
Third Intervention Period: Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition
Yarosslavl Clinical Hospital #3
Yaroslavl, Russia
Cmax
Pharmacokinetics of metformin by Assessment of Observed Maximum Plasma Concentration (Cmax)
Time frame: 0 hours (pre-dose), as well as at 0.5, 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 30.0 and 36 hours post-dose
AUC(0-t)
Pharmacokinetics of metformin by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
Time frame: 0 hours (pre-dose), as well as at 0.5, 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 30.0 and 36 hours post-dose
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Fourth Intervention Period: Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition