Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects
Condition: Bioequivalence, AUC, Cmax, Pharmacokinetics
Intervention: Memantinol tablets, 20 mg; Akatinol Memantine® tablets, 20 mg
Intervention description: 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
Intervention MeSH terms: Memantine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: two-way crossover
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent form.

          -  Healthy male and female subjects aged 18 to 45 years.

          -  Verified diagnosis is "healthy" according to data Standard clinical, laboratory and
             Instrumental methods of examination.

          -  Have a body mass index between 18,5 and 27 kg/m2.

          -  Females must have a negative pregnancy test.

          -  Subjects must use, with their partner, methods of highly effective contraception; if
             the Hormonal contraceptives was used they must canceled have at least 2 month before
             the study.

        from the time of IMP administration until 3 months after the last dose of IMP.

        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.