Conditions: Bioequivalence, AUC, Cmax, Pharmacokinetics
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 18
Healthy volunteers: yes

Brief summary:
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

Detailed description:
Study to evaluate the bioequivalence of orally administered memantinol preparations, film-coated tablets, 20 mg

Arms:
arm 1: Treatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC "GEROPHARM", Russia - test) arm 2: Treatment B: a single oral dose of memantin 20 mg film-coated tablet (Merz Pharma GmbH \& Co. KGaA, Germany - reference)

Interventions: intervention 1: Memantinol tablets, 20 mg intervention 2: Akatinol Memantine® tablets, 20 mg
Intervention descriptions: intervention 1: Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition intervention 2: Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg film-coated tablets fasting condition

Protocol document: