Clinical trial NCT03121820: Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence, AUC, Cmax, Pharmacokinetics
Lead sponsor: Geropharm
Sponsor class: INDUSTRY
First posted: 2017-04-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: two-way crossover
Primary purpose: BASIC_SCIENCE

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

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.

Primary outcomes:
measure: Pharmacokinetics of Memantinol by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))
timeFrame: 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
measure: Pharmacokinetics of Memantinol by Assessment of Observed Maximum Plasma Concentration (Cmax)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: City Clinical Hospital № 15 named. O.M.filatova
Study officials:
affiliation: Igor.Makarenko@geropharm.com
name: Igor Makarenko, MD, PhD
role: STUDY_CHAIR
References: