Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects

Exclusion Criteria

• •History of serious allergic problems/events
• •Medicinal intolerance.
• •History of allergic reactions to memantine or investigator's product components
• •Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrinal systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
• •Acute infectious diseases in less than 4 weeks before the start of the study.
• •Subjects who have taken medication 4 weeks preceding before the study.
• •Subjects who have taken any drugs known effects on hemodynamics or to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, omeprazole, etc.).
• •Donation of plasma (450 mL or more) within 2 month prior to administration of the study medication.
• •History of significant alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
• •Smokers.
• •Participation in other clinical training is less than than for 3 months before the study.
• •Lack of signed informed consent form.
• •ECG or vital signs abnormalities (clinically significant).
• •Positive testing for alcohol, drugs, pregnancy.