Cimantin Mechanism of Action

Pharmacotherapeutic group: Anti-dementia drugs. ATC code: N06DX01.
Pharmacology: Pharmacodynamics: There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at NMDA-receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia.
Memantine is a voltage-dependent, moderate-affinity uncompetitive NMDA-receptor antagonist. It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction.
Pharmacokinetics: The pharmacokinetics parameters of 16 subjects (16 subjects were included in the study and all 16 subjects completed all 2 study periods) were calculated and results were statistically analyzed to demonstrate bioequivalence in a 2-period, crossover design study. After oral administration of Memantine HCl 10 mg film coated tablets (test product) the mean of the maximum plasma concentration (C_max) (rate of absorption) was 12.32 ng/mL the mean T_max 6.31 h. The extent of absorption is expressed in Area Under the Curve (AUC)_0-72 and AUC_0-inf the mean values were 576.54 ng·h/mL and 891.98 ng·h/mL respectively. The mean elimination half life (T_1/2) of Memantine HCl 10 mg film coated tablets was 47.68 h.
The ratios and confidence intervals between test and reference product were as following: for C_max the ratio was 98.89% (95.52% - 102.39%). For AUC_0-72 the ratio was 99.33% (96.36% - 102.38%). The results of the study showed that the ratios and confidence intervals are within the acceptance range for bioequivalence, therefore it can be concluded that the test product, Memantine HCl 10 mg film coated tablets, is bioequivalence with the reference product.