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

NCT ID: NCT03121820

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-11
• Study Completion Date: 2016-11-19

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

Conditions

Bioequivalence, AUC, Cmax, Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Memantinol tablets, 20 mg

Treatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC "GEROPHARM", Russia - test)

Group Type: EXPERIMENTAL

Memantinol tablets, 20 mg

Intervention Type: DRUG

Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition

Akatinol Memantine® tablets, 20 mg

Treatment B: a single oral dose of memantin 20 mg film-coated tablet (Merz Pharma GmbH \& Co. KGaA, Germany - reference)

Group Type: ACTIVE_COMPARATOR

Akatinol Memantine® tablets, 20 mg

Intervention Type: DRUG

Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg film-coated tablets fasting condition

Interventions

Memantinol tablets, 20 mg

Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition

Intervention Type: DRUG

Akatinol Memantine® tablets, 20 mg

Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg film-coated tablets fasting condition

Intervention Type: DRUG

Other Intervention Names

memantine; memantine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Geropharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Igor Makarenko, MD, PhD

Role: STUDY_CHAIR

Igor.Makarenko@geropharm.com

Locations

City Clinical Hospital № 15 named. O.M.filatova

Moscow, , Russia

Countries

Russia

Other Identifiers

BIOMEM-20

Identifier Type: -

Identifier Source: org_study_id