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

NCT03121820 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-10-29

Study results available
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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

Interventions

DRUG

Memantinol tablets, 20 mg

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

DRUG

Akatinol Memantine® tablets, 20 mg

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

Sponsors & Collaborators

  • Geropharm

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-11
Primary Completion
2016-11-19
Completion
2016-11-19

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03121820 on ClinicalTrials.gov