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Trial record 82 of 1357 for:    Area Under Curve AND tablet

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

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ClinicalTrials.gov Identifier: NCT03121820
Recruitment Status : Completed
First Posted : April 20, 2017
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Geropharm

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

Condition or disease Intervention/treatment Phase
Bioequivalence, AUC, Cmax, Pharmacokinetics Drug: Memantinol tablets, 20 mg Drug: Akatinol Memantine® tablets, 20 mg Phase 1

Detailed Description:
Study to evaluate the bioequivalence of orally administered memantinol preparations, film-coated tablets, 20 mg

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: two-way crossover
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Basic Science
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
Actual Study Start Date : October 11, 2016
Actual Primary Completion Date : November 19, 2016
Actual Study Completion Date : November 19, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Memantinol tablets, 20 mg
Treatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC "GEROPHARM", Russia - test)
Drug: Memantinol tablets, 20 mg
Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition
Other Name: memantine

Active Comparator: 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)
Drug: Akatinol Memantine® tablets, 20 mg
Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH & Co. KGaA, Germany) 20 mg film-coated tablets fasting condition
Other Name: memantine




Primary Outcome Measures :
  1. Pharmacokinetics of Memantinol by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf)) [ Time Frame: 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 ]
    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)

  2. Pharmacokinetics of Memantinol by Assessment of Observed Maximum Plasma Concentration (Cmax) [ Time Frame: 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 ]
    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)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121820


Locations
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Russian Federation
City Clinical Hospital № 15 named. O.M.filatova
Moscow, Russian Federation
Sponsors and Collaborators
Geropharm
Investigators
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Study Chair: Igor Makarenko, MD, PhD Igor.Makarenko@geropharm.com

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Responsible Party: Geropharm
ClinicalTrials.gov Identifier: NCT03121820     History of Changes
Other Study ID Numbers: BIOMEM-20
First Posted: April 20, 2017    Key Record Dates
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents