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

Study Overview
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Brief Summary
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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
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Study to evaluate the bioequivalence of orally administered memantinol preparations, film-coated tablets, 20 mg

Official Title
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A 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

Conditions
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Bioequivalence, AUC, Cmax, Pharmacokinetics

Intervention / Treatment
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* Drug: Memantinol tablets, 20 mg
* Drug: Akatinol Memantine® tablets, 20 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: two-way crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memantinol tablets, 20 mg<br>Treatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC GEROPHARM, Russia - test) | Drug: Memantinol tablets, 20 mg<br>* Bioequivalence Memantine Hydrochloride (JSC GEROPHARM, Russia) 20 mg film-coated tablets fasting condition<br>* Other names: memantine;|
| Active Comparator: Akatinol Memantine® tablets, 20 mg<br>Treatment B: a single oral dose of memantin 20 mg film-coated tablet (Merz Pharma GmbH & Co. KGaA, Germany - reference) | Drug: Akatinol Memantine® tablets, 20 mg<br>* Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH & Co. KGaA, Germany) 20 mg film-coated tablets fasting condition<br>* Other names: memantine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 |