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

NCT03121820 | Completed Phase 1 Results DMC

• 1 other identifier: BIOMEM-20
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Bioequivalence, AUC, Cmax, Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Memantinol tablets, 20 mg

EXPERIMENTAL

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

Drug: Memantinol tablets, 20 mg

Akatinol Memantine® tablets, 20 mg

ACTIVE COMPARATOR

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

Interventions

Memantinol tablets, 20 mg DRUG

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

Also known as: memantine

Memantinol tablets, 20 mg

Akatinol Memantine® tablets, 20 mg DRUG

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

Also known as: memantine

Akatinol Memantine® tablets, 20 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Geropharm: lead

Study Sites (1)

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

Moscow, Russia

Location

MeSH Terms

Interventions

Memantine

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: GEROPHARM Clinical Leader
• Organization: GEROPHARM

inform@geropharm.ru

+7(812) 703-79-75

Study Officials

• Igor Makarenko, MD, PhD

  Igor.Makarenko@geropharm.com

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two-way crossover

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 20, 2017
• Study Start: October 11, 2016
• Primary Completion: November 19, 2016
• Study Completion: November 19, 2016
• Last Updated: October 29, 2018
• Results First Posted: October 29, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)