NCT03121820

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Geropharm · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

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

Conditions

• Bioequivalence, AUC, Cmax, Pharmacokinetics

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-10-11
• Primary completion: 2016-11-19
• Completion: 2016-11-19
• First posted: 2017-04-20
• Last updated: 2018-10-29
• Results posted: 2018-10-29

Locations

1 site across 1 country: Russia