NCT03121820

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

Completed Phase 1 Results posted Last updated 29 October 2018

What this trial tests

Phase 1 trial testing Memantinol tablets, 20 mg in Bioequivalence, AUC, Cmax, Pharmacokinetics in 18 participants. Completed in 19 November 2016.

Timeline

11 October 2016

Primary endpoint
19 November 2016

19 November 2016

Quick facts

Lead sponsor	Geropharm
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	18
Start date	11 October 2016
Primary completion	19 November 2016
Estimated completion	19 November 2016
Sites	1 location across Russia

Drugs / interventions tested

• Memantinol tablets, 20 mg — full drug profile →
• Akatinol Memantine® tablets, 20 mg — full drug profile →

Conditions studied

• Bioequivalence, AUC, Cmax, Pharmacokinetics — all drugs for Bioequivalence, AUC, Cmax, Pharmacokinetics →

Sponsor

Geropharm — full company profile →

Who can join

Adults 18 to 45, any sex, with Bioequivalence, AUC, Cmax, Pharmacokinetics. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharmacokinetics of Memantinol by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf)) Primary · 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)

Group	Value	95% CI
Memantinol Tablets, 20 mg	1920.362	± 449.289
Akatinol Memantine® Tablets, 20 mg	2096.669	± 537.147

Pharmacokinetics of Memantinol by Assessment of Observed Maximum Plasma Concentration (Cmax) Primary · 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)

Group	Value	95% CI
Memantinol Tablets, 20 mg	34.617	± 8.302
Akatinol Memantine® Tablets, 20 mg	37.578	± 8.858

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Memantinol Tablets, 20 mg

Serious: 0/18 (0%)

Deaths: —

Akatinol Memantine® Tablets, 20 mg

Serious: 0/18 (0%)

Deaths: —

Other adverse events (1 terms — click to expand)

Reaction	System	Memantinol Tablets, 20 mg	Akatinol Memantine® Tablet…
Dizziness	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT03121820 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Memantine hydrochloride: a drug to be repurposed against Chikungunya virus?
   Pereira AKDS, Santos IA, da Silva WW, Nogueira FAR, et al · · 2021 · cited 8× · PMID 33523405 · DOI 10.1007/s43440-021-00216-4