This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg tablets in normal healthy subjects
Study to evaluate the bioequivalence of orally administered memantinol preparations, film-coated tablets, 20 mg
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition
Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg film-coated tablets fasting condition
City Clinical Hospital № 15 named. O.M.filatova
Moscow, Russia
Pharmacokinetics of Memantinol by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))
Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf), of memantinol sourced in Memantinol® (JSC "GEROPHARM", Russia) and Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany)
Time frame: 0 hours (pre-dose), as well as at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
Pharmacokinetics of Memantinol by Assessment of Observed Maximum Plasma Concentration (Cmax)
Comparison of the pharmacokinetic profile in terms of observed maximum plasma concentration, taken directly from the individual concentration-time curve, Cmax, of memantinol sourced in Memantinol® (JSC "GEROPHARM", Russia) and Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany)
Time frame: 0 hours (pre-dose), as well as at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose
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