Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Study to evaluate the bioequivalence of orally administered memantinol preparations, film-coated tablets, 20 mg
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memantinol tablets, 20 mg | Experimental | Treatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC "GEROPHARM", Russia - test) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantinol tablets, 20 mg | Drug | Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
from the time of IMP administration until 3 months after the last dose of IMP.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Igor Makarenko, MD, PhD | Igor.Makarenko@geropharm.com | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City Clinical Hospital № 15 named. O.M.filatova | Moscow | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
18 participants recruited; 25 screened, 7 excluded (5 did not meet inclusion criteria and 2 refused participation).
Participants recruited at GKB № 15 im. O. M. Filatova Public Healthcare Institution of Department of health care of Moscow, Russian Federation between October and November 2016
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Memantinol First, Then Akatinol Memantine® | First Intervention Period (3 day): Memantinol tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state (21 day washout period) Second Intervention Period (3 day): Akatinol Memantine® tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Period |
|
Not provided
Not provided
Not provided
two-way crossover
Not provided
Not provided
Open Label
Not provided
|
| Akatinol Memantine® tablets, 20 mg | Drug | Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH & Co. KGaA, Germany) 20 mg film-coated tablets fasting condition |
|
|
| FG001 |
| Akatinol Memantine® First, Then Memantinol |
First Intervention Period (3 day): Akatinol Memantine® tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state (21 day washout period) Second Intervention Period (3 day): Memantinol tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state |
| COMPLETED |
|
| NOT COMPLETED |
|
| Second Period (After Washout) |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Memantinol First, Then Akatinol Memantine® | First Intervention Period (3 day): Memantinol tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state (21 day washout period) Second Intervention Period (3 day): Akatinol Memantine® tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state |
| BG001 | Akatinol Memantine® First, Then Memantinol | First Intervention Period (3 day): Akatinol Memantine® tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state (21 day washout period) Second Intervention Period (3 day): Memantinol tablet: Single administered dose of Memantinol ( 20 mg memantin) in a fasting state |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 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 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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) | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Memantinol Tablets, 20 mg | Active experimental drug Memantinol: Single orally administered dose of Memantinol (20 mg memantine) in a fasting state | 0 | 18 | 2 | 18 | ||
| EG001 | Akatinol Memantine® Tablets, 20 mg | Active comparator Akatinol Memantine®: Single orally administered dose of Akatinol Memantine® (20 mg memantine) in a fasting state | 0 | 18 | 2 | 18 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment | The volunteers during period, 2.5 hours after taking the test drug (20 mg orally) was dizzy. Deviations in any Analyzed indicators were not revealed. There was no volunteer Action taken. AE resolved full recovery. |
|
If a publication (e.g., in a scientific journal) based on the results of this study is envisaged, approval from GEROPHARM will be obtained and a draft manuscript will be submitted to GEROPHARM for scrutiny and comment. The choice of conduit will be mutually agreed on by the Principal Investigator and GEROPHARM.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GEROPHARM Clinical Leader | GEROPHARM | +7(812) 703-79-75 | inform@geropharm.ru |
| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Participants |
|
|
|