Trial Outcomes & Findings for Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects (NCT NCT03121820)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

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

Results posted on

2018-10-29

Participant Flow

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

18 participants recruited; 25 screened, 7 excluded (5 did not meet inclusion criteria and 2 refused participation).

Participant milestones

Participant milestones
Measure	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	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
First Period STARTED	9	9
First Period COMPLETED	9	9
First Period NOT COMPLETED	0	0
Second Period (After Washout) STARTED	9	9
Second Period (After Washout) COMPLETED	9	9
Second Period (After Washout) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Memantinol First, Then Akatinol Memantine® n=9 Participants 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	Akatinol Memantine® First, Then Memantinol n=9 Participants 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	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Memantinol Tablets, 20 mg n=18 Participants Treatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC "GEROPHARM", Russia - test) Memantinol tablets, 20 mg: Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition	Akatinol Memantine® Tablets, 20 mg n=18 Participants Treatment B: a single oral dose of memantin 20 mg film-coated tablet (Merz Pharma GmbH \& Co. KGaA, Germany - reference) Akatinol Memantine® tablets, 20 mg: Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg film-coated tablets fasting condition
Pharmacokinetics of Memantinol by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))	1920.362 ng*h/mL Geometric Coefficient of Variation 449.289	2096.669 ng*h/mL Geometric Coefficient of Variation 537.147

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Memantinol Tablets, 20 mg n=18 Participants Treatment A: a single oral dose of memantin 20 mg film-coated tablet (JSC "GEROPHARM", Russia - test) Memantinol tablets, 20 mg: Bioequivalence Memantine Hydrochloride (JSC "GEROPHARM", Russia) 20 mg film-coated tablets fasting condition	Akatinol Memantine® Tablets, 20 mg n=18 Participants Treatment B: a single oral dose of memantin 20 mg film-coated tablet (Merz Pharma GmbH \& Co. KGaA, Germany - reference) Akatinol Memantine® tablets, 20 mg: Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg film-coated tablets fasting condition
Pharmacokinetics of Memantinol by Assessment of Observed Maximum Plasma Concentration (Cmax)	34.617 ng/mL Geometric Coefficient of Variation 8.302	37.578 ng/mL Geometric Coefficient of Variation 8.858

Adverse Events

Memantinol Tablets, 20 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Akatinol Memantine® Tablets, 20 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Memantinol Tablets, 20 mg n=18 participants at risk Active experimental drug Memantinol: Single orally administered dose of Memantinol (20 mg memantine) in a fasting state	Akatinol Memantine® Tablets, 20 mg n=18 participants at risk Active comparator Akatinol Memantine®: Single orally administered dose of Akatinol Memantine® (20 mg memantine) in a fasting state
Nervous system disorders Dizziness	11.1% 2/18	11.1% 2/18

Additional Information

GEROPHARM Clinical Leader

GEROPHARM

Phone: +7(812) 703-79-75

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER